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VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target

This study has been transitioned to CTIS with ID 2024-514183-21-00 check the CTIS register for the current data. The primary objective of this trial is to determine whether, in subjects with moderately to severely active UC, treating to achieve a…

Efficacy of vaccine responses against SARS-Cov-2 in patients with giant cell arteritis and polymyalgia rheumatica (GPSVAC)

The main objective of this study is to assess effectiveness of the COVID-19 vaccinations, based on humoral (anti-coronavirus antibody) immunity, in GCA and PMR patients. Other objectives are assessing antigen-specific cellular (T-cell) immune…

INSIDE-LRP: Non-Invasive Identification with Computed Tomography Coronary Angiography of Vulnerable Lipid-Rich Plaques

To develop a non-invasive algorithm that allows the detection of LRPs with CTCA

An open label, multi-center roll-over study to assess long-term safety in patients who are ongoing or have completed a prior global Novartis or GSK sponsored Tafinlar (dabrafenib) and/or Mekinist (trametinib) study and are judged by the investigator to benefit from continued treatment

This study has been transitioned to CTIS with ID 2023-509318-13-00 check the CTIS register for the current data. This is an open-label, multi-center, roll-over study designed to provide continued access to subjects who have previously participated…

VAginal NOTES versus Laparoscopic hysterectomy in Uterine Endometrioid Cancer (VALUE-study): a multicentre randomized trial.

To evaluate the duration of admission, feasibility, patient satisfaction and complication rate of vNOTES hysterectomy with BSO and compare it with laparoscopic hysterectomy with BSO in case of clinical stage 1 low grade endometrial cancer.

The glutamate/GABA balance as novel therapeutic target for psychotic and cognitive symptoms in 22q11.2 deletion syndrome

The objective of this study is to examine the effect of riluzole on the glutamate/GABA balance in the brain in patients with 22q11.2DS. The secondary objective is to examine the effects of riluzole on psychotic symptoms and cognitive functioning. In…

Chronotherapy in Inflammatory Arthritis (ChronIA trial): a randomized controlled trial comparing the effectiveness of morning and evening dosing of tofacitinib extended-release

This study has been transitioned to CTIS with ID 2024-517865-17-00 check the CTIS register for the current data. We hypothesize that the timing of treatment in IA, also known as chronotherapy, matters and that the efficacy of tofacitinib XR depends…

Suboxone (buprenorphine/naloxone) versus methadone opioid rotation in patients with escalated opioid use and chronic pain: a randomized trial.

This study has been transitioned to CTIS with ID 2024-513924-41-01 check the CTIS register for the current data. The primary objective of this study is to compare effectivity of suboxone and methadone on reducing opioid misuse.Secondary objectives…

Better after Choosing: Randomly allocated or patient preference based treatment with Filgotinib or TNFi in patients with active Rheumatoid Arthritis: the *BACH* study

primary objectives- To evaluate the actual preference of patients when they decide themselves which mode of action they want to use for treatment of rheumatoid arthritis.- To evaluate differences in treatment satisfaction between patients who choose…

A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing (DMR) Using the Revita® System in Subjects with Type 2 Diabetes on Insulin therapy

To assess the efficacy of Revita® DMR for improving HbA1c to <= 7% without the need of insulin in subjects with T2D compared to sham.To assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints.

Tailoring P2Y12 Inhibiting Therapy in Patients requiring Oral Anticoagulation after undergoing Percutaneous Coronary Intervention: The Switching Anti-Platelet and Anti-Coagulant Therapy - 2 Study

The aim of this study is to assess the pharmacodynamic effects of different P2Y12 inhibiting therapy (clopdiogrel vs ticagrelor) in patients at high risk for HPR identified according to the ABCD-GENE score in PCI treated patients also requiring OAC…

Five-year boostability after single-visit single-dose intramuscular rabies pre-exposure prophylaxis.

The aim of this study is to demonstrate that a single dose of rabies vaccine can induce an equally rapid and adequate anamnestic antibody response as 2-dose PrEP to revaccination five years later.

Genotype-guided strategy for antithrombotic treatment versus conventional clopidogrel therapy in peripheral arterial disease.

This study has been transitioned to CTIS with ID 2024-518122-33-00 check the CTIS register for the current data. The primary aim of the GENPAD study is to evaluate the ability of genotype-guided antithrombotic treatment to reduce adverse clinical…

Reversal of opioid-induced respiratory depression with opioid antagonists - a study in opioid naïve individuals and chronic opioid users under real-life conditions

This study has been transitioned to CTIS with ID 2024-518041-16-00 check the CTIS register for the current data. The goal of the studies is multiple:1. To describe the pharmacokinetics of intravenously administered fentanyl and sufentanil;2. To…

Erector spinae plane block for reduction of early postoperative pain scores and opioid use in lumbar spinal fusion surgery, a prospective double-blinded randomized placebo-controlled trial

The objective of this study is to evaluate the analgesic effect of ESPB as add-on therapy to multimodal analgesia on early postoperative pain after lumbar spinal fusion surgery compared to placebo.

Prediction of Response Of horMOnal Treatment in advanced and recurrent Endometrial cancer

Primary Objective: Validation of the response prediction algorithm to hormonal therapy defined as response rate, progression free survival (PFS) and clinical benefit rate (CBR). Secondary Objectives: • Health-related quality of life in patients with…

The perioperative renal and metabolic outcomes after sodium-glucose cotransporter-2 inhibitor in cardiac surgery - an open-label phase IV randomized controlled trial

To investigate the potential of preoperative initiation (7 days) and perioperative continuation (until day 2 after surgery) of empagliflozin 10 mg daily to reduce the acute kidney injury marker neutrophil gelatinase-associated lipocalin (NGAL) on…

Anticoagulant medicines for Balloon Pulmonary Angioplasty

This study has been transitioned to CTIS with ID 2024-518803-23-00 check the CTIS register for the current data. To evaluate the safety and efficacy of DOAC versus VKA in CTEPH/CTED patients receiving BPA, based on the composite endpoint of…

GAG-therapy Efficacy Trial Solution for Bladder pain syndrome/ Interstitial cystitis

Main objective is to determine short and long term efficacy of GAG therapy (bladder instillations) for people with BPS-IC H+ as compared to placebo treatment on dominant symptoms such as pain. Secondary objectives are to determine the 1) cost-…

A nationwide multicentre, open-label study of six months avelumab maintenance treatment in patients with locally advanced or metastatic urothelial cancer whose disease did not progress after at least 4 cycles of first-line platinum-containing chemotherapy and the opportunity to re-treat

This study has been transitioned to CTIS with ID 2024-512975-11-01 check the CTIS register for the current data. To demonstrate benefit of maintenance treatment with avelumab for a maximum of six months avelumab in increasing overall survival (OS)…