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A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein (a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with established cardiovascular disease (CVD).

This study has been transitioned to CTIS with ID 2023-508292-37-00 check the CTIS register for the current data. The study has two primary objectives addressing the same scientific hypothesis: one in the full study population who is at a high risk…

The Sagittal Plane Shear Index (SPSI) for planning whether to fuse
after decompressing a stenotic lumbar level

To assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple treatment algorithm

A phase 3B, open-label, single-arm, rollover study to evaluate long-term safety in subjects who have participated in other Luspatercept (ACE-536) clinical trials.

This study has been transitioned to CTIS with ID 2022-502498-40-00 check the CTIS register for the current data. Primary Objective: To evaluate the long-term safety (including progression to acute myeloid leukemia (AML) and/or other malignancies/pre…

REC2Stim as a treatment for refractory epilepsy in the sensorimotor cortex

We propose cortical electrical stimulation therapy of a conceptually novel type. We systematically determine individual settings, stimulation site and seizure detection algorithm in a predictive model. In REC2Stim (Rational Extra-eloquent Closed-…

Distribution of Endoscopic and Histologic Healing in Ulcerative Colitis

To determine the anatomic distribution of endoscopic and histologic improvement in patients with pancolonic ulcerative colitis (UC) after 16 to 24 weeks of treatment with a biologic or tofacitinib therapy.

Improving Treatment Options for Somatostatin Type 2 Receptor Negative Neuroendocrine Tumor Patients

The aim of this prospective proof-of-concept study is to increase the expression of the SSTR2 in NET patients with negative or low expression to levels amenable for somatostatin analogue treatment through the use of epigenetic drugs.

A study of a non-invasive measurement method for idiopathic pulmonary fibrosis patients. The predictive value of the IOS for the degree of fibrosis compared to the lung function test.

This study investigates the correlation between IOS and the severity of fibrosis on HRCT in patients with IPF. It also investigates which IOS parameter best relates to the degree of fibrosis on the HRCT. Furthermore, as a secondary endpoint, it is…

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS

Objective(s): Primary objective:The primary objective is to demonstrate the efficacy of bimekizumab administered subcutaneously (sc) every 4 weeks (Q4W) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).…

Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics , Pharmacodynamics, and Efficacy of CLN-081 in Patients with Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy

Phase 1Primary ObjectivesTo assess the safety and tolerability of orally administered CLN-081 monotherapy.To define the maximum tolerated dose (MTD) of orally administered CLN-081 monotherapy.Secondary ObjectivesTo assess the anti-tumor activity.To…

A 12-month, open-label, multicenter, randomized, safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) study of two regimens of anti-CD40 monoclonal antibody, CFZ533 vs. standard of care control, in adult de novo liver transplant recipients with a 12-month additional follow-up and a long-term extension (CONTRAIL I).

This study will allow the assessment of the ability of CFZ533 to replace calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing potentially better renal function with an expected similar safety and tolerability profile.…

A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy in subjects with DIPSS - intermediate or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis and previously treated with ruxolitinib

The primary objective of the study is to evaluate the percentage of subjects with at least 35%spleen volume reduction in the fedratinib and the BAT arms.The secondary objectives are:• To evaluate the percentage of subjects with at least 50%…

Dorsal dislocations or hyperextension injuries with a volar plate avulsion of the proximal interphalangeal joint, conservative treatment with or without supervised hand-therapy?

To compare the functional outcome and cost-effectiveness of self-management exercise regimen versus supervised hand-physiotherapy. The patient group exists of adults who are treated conservatively because of dorsal dislocation or hyperextension…

Cardiac changes after stereotactic radiotherapy for early stage NSCLC cancer or lung metastasis - HALO

We aim to optimize the radiation treatment of early stage lung cancer patients. Cardiac sparing is possible, but it comes at the cost of an increased mean lung dose. Without proof of cardiac toxicity, cardiac sparing will not be (routinely) applied…

B cell Activation in Sjögren's Syndrome, Cutaneous Lupus Erythematodus and Systemic Sclerosis Tissues Analysis 2

The objective of this study is to investigate of inflammatory tissues of patients with SSj, CLE and SSc contain autoreactive B and T cell expansions that are differently activated compared to other B and T cell expansions in patients with SSj, CLE…

Effectiveness of Small Size Interarcuair Decompression versus Extended Decompression in patients with intermittent neurogenic claudication (SIZE-study): a multi-centre, double-blinded randomized controlled trial

Primary Objective: To investigate whether small size interarcuair decompression is more effective than conventional laminectomy in patients with INC caused by LSS. Secondary Objective(s): To investigate whether small size interarcuair decompression…

Efficiency of a blended care version of an effective diabetes diet

Primary Objective: 1. What is the efficiency of a blended care version of the POWER diet (Blended POWER), compared to the POWER diet used in usual care (usual care POWER program): is Blended POWER equally effective in reducing weight after 1 year in…