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Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2)

To test if a CRT-targeted resuscitation based on clinical hemodynamic phenotyping can improve a hierarchical clinical outcome - mortality, time to cessation of vital organ support, and length of hospital stay, all within 28 days - in septic shock…

The effect of mindfulness-based cognitive therapy on psychological distress in people with Parkinson*s Disease: clinical effects and cerebral mechanisms.

Test whether a mindfulness-based cognitive therapy intervention (MBCT) improves psychological distress, clinical symptoms, slows neurodegeneration, and/or enhances neuroplasticity in PD.

Telemonitoring and E-Coaching in Hypertension

To determine the effects of the PCP+SM compared with usual care on BP control in adults with hypertension. To determine the effects of the PCP+SM compared with usual care on antihypertensive medication use in adults with hypertension. To determine…

Preventing recurrent *idiopathic* acute pancreatitis through laparoscopic cholecystectomy (PICUS-2):
a multicenter randomized trial

The goal of this trial is to determine the efficacy of LC in patients with IAP in the prevention of recurrent acute pancreatitis and biliary events. The secondary goal of this trial is to assess the occurrence of biliary events, complications of LC…

The Rainbow Study - A Randomized Controlled Trial to Evaluate the effect of Personalized Feedback on Symptom Perception in Asthmatic Children

Primary objective :How does measuring lung function and VAS at home with personalized feedback based on the Rainbow tool influence the perception of asthma related symptoms of asthmatic children? Secundary objectives: -Is there an additional effect…

Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)

This study has been transitioned to CTIS with ID 2023-508926-91-00 check the CTIS register for the current data. To determine non-inferiority of preoperative 6 weeks of VCE to VAD in the overall metastatic rapid response rate (MetRR) in newly…

Dupuytren*s disease Evaluation of Preventative or Adjuvant Radiation Therapy

Primary objective: To show a meaningful reduction in progression of DD with the application of radiotherapy both in the early stages as well as following local treatment in the later stages.Secondary objectives: 1. Report physician graded toxicity…

Goal directed fluid removal with furosemide in intensive care patients with fluid overload - A randomised, blinded, placebo-controlled trial

This study has been transitioned to CTIS with ID 2024-512186-14-00 check the CTIS register for the current data. To assess benefits and harms of goal directed fluid removal with furosemide versus placebo on patient-important outcome measures in…

Randomized Controlled Trial comparing imaging-based programming with threshold-assessment based programming of Deep Brain Stimulation in Parkinson's Disease.

The aim of this study is to assess whether the effectiveness of STN DBS for the treatment of Parkinson motor symptoms using imaging-based DBS programming is non-inferior compared to DBS programming with the current standard practice of clinical…

Peripheral nerve stimulation to improve learning

The main objective of the proposed study is to investigate the effect of PNS as a means to support the learning process in order to accelerate learning and improve knowledge and competence retention. This will be tested by applying PNS stimulation…

Mean arterial pressure alarm compared to hypotension prediction index in preventing intraoperative hypotension

Primary Objective: The performance in preventing intraoperative hypotension of a MAP treatment alarm of 72 mmHg compared to the performance of the HPI alarm. Secondary Objectives: - The correlation between the MAP signal and HPI signal - The…

Neural plasticity and recovery after early and intensive upper extremity motor training in people with cervical spinal cord injury.

This project aims to investigate peripheral and central neuroplasticity following an early (<13 weeks after injury) and intensive (8 weeks of 6 hours of additional therapy) upper extremity motor training program (EIUMT) aimed at recovery…

Dye chromoENDOscopy versus virtual chromoendoscopy for assessment of the ileo-anal pouch in patients with familial adenomatous POLyposis: a randomized controlled trial

The primary outcome of this study is the detection of clinical relevant adenomas (>= 5mm) in the ileal pouch.

A Multi-Center Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects with an Acute Gout Flare

This study has been transitioned to CTIS with ID 2024-518844-20-00 check the CTIS register for the current data. Primary Objective:To evaluate the efficacy of dapansutrile as an acute gout flare treatment compared to placebo in reducing joint pain…

A new perspective: Development of a cognitive behavioral therapeutic intervention for patients with remaining trauma related symptoms

The goal of the study is to explore the effects on quality of life of an experimental treatment module that attempts to change trauma related attributions and cognitions in patients with remaining PTSD symptoms.

Active vitamin D for secondary hyperparathyroidism after bariatric surgery: a multicenter randomized controlled trial.

This study has been transitioned to CTIS with ID 2023-510312-40-00 check the CTIS register for the current data. Main objective- to investigate the effect of alfacalcidol on the treatment of secondary hyperparathyroidism in patients after RYGB…

Appropriate use of Blood Cultures in the emergency department through machine learning: a randomized controlled trial.

The aim of this study is to see whether we can safely use blood cultures more efficiently. By using a prediction model, we support the clinical decision to analyse a blood culture. If the chance that this culture yields a positive result is very…

ICONIC-M: IMPROVING CRT OUTCOME WITH NON-INVASIVE CARDIAC MAPPING;A multicentre randomised controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empiric lead placement.

The primary objectives of this investigation are to evaluate whether pre-acquired Amycard ECGI map-guided LV lead placement (I) improves CRT volumetric response compared to non-guided (empiric) LV lead placement, and (II) reduces the distance to LV…

COLLISION RELAPSE trial - Recurrent colorectal liver metastases: repeat local treatment +/- neoadjuvant systemic therapy - a phase III prospective randomized controlled trial

This study has been transitioned to CTIS with ID 2024-515341-41-01 check the CTIS register for the current data. The primary objective is to demonstrate superiority of neoadjuvant systemic therapy followed by repeat local treatment as compared to…

Percutaneous versus surgical VA ECMO insertion:
a pilot study to evaluate feasibility and safety

Primary objectivesAs our primary efficacy objective, we will compare procedural success rate between the two groups, which is defined as defined as the successful insertion of both arterial and venous cannulas and subsequent initiation of ECMO-flow…