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Transcranial magnetic stimulation (TMS) for patients with exposure therapy-resistant obsessive-compulsive disorder (OCD): TETRO - a multicenter randomized controlled trial

We aim to fill the gap between the 50% of patients helped by standard therapies (ERP with/without SSRIs) and the 1% receiving surgery by using a non-invasive alternative: repetitive transcranial magnetic stimulation (rTMS) to potentiate the effects…

MOODSTRATIFICATION IMMUNOSTRATA Groningen
Premature immune ageing and spinning therapy in mood disorders

Primary objective:To assess whether the state of premature immune ageing (senescent CD8+ T cells) modify treatment response to physical endurance intervention therapy in depressed patients. We will compare the mood-beneficial effects of physical…

Mental Health Promotion and Intervention in Occupational Settings (MENTUPP): a cluster-Randomized Controlled Trial

The primary objective of the MENTUPP research project is to improve mental health in the workplace by developing, implementing and evaluating the effectiveness of a multicomponent intervention (MENTUPP) targeting mental health difficulties (non-…

Tirzepatide Study of Renal Function in People with Overweight or Obesity and
Chronic Kidney Disease with or without Type 2 Diabetes: Focus on Kidney
Hypoxia in Relation to Fatty Kidney Disease using Multiparametric Magnetic
Resonance Imaging (TREASURE-CKD)

This study has been transitioned to CTIS with ID 2023-506082-60-00 check the CTIS register for the current data. The objective of this study is to investigate the mechanism(s) of action of tirzepatide in the kidney, in participants who are…

3D Virtual Surgery In an Orthopaedic-trauma Network
(3D ViSION trial)
A randomised-controlled study initiated by the department of Trauma Surgery, Orthopaedic Surgery and the 3D lab of the University Medical Center Groningen

To assess the following research questions: 1. Does the use of 3D virtual preoperative planning of surgery improve functional outcome as measured by Patient-Reported Outcome in comparison to conventional surgery (using conventional radiographs and/…

Transcutaneous electrical nerve stimulation in persons with MS

Primary Objective:What is the effect of a four-weeks combined TENS and exercise program, in comparison with no training, an exercise program or TENS only program, on the walking capability, perceived walking disability, and sense of fatigue of pwMS.…

A randomized, double-blind, placebo-controlled, two parallel groups, international multicenter trial to evaluate the effect of Plerixafor in acute respiratory failure related to COVID-19 (LEONARDO)

To demonstrate that Plerixafor is able to reduce the need for invasive mechanical ventilation or death in severe COVID-19 patients admitted in Intensive Care Unit (ICU)

Evaluation of a PReparatory eHealth intervention for patients in CArdiac REhabilitation: a pilot study.

To assess the feasibility of a tailored eHealth intervention (primary) for cardiac patients with a low socio-economic position and explore its effect on patient activation, certainty and guidance (secondary) compared to usual care.

A Randomised Double-Blind Placebo-Controlled Phase III Clinical
Study to Evaluate the Efficacy and Safety of Cobitolimod as an
Induction and Maintenance Therapy in Participants with Moderate
to Severe Active Left-Sided Ulcerative Colitis

Study Objectives:Primary Objective: InductionTo evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC.Secondary Objectives: Induction• To…

A randomised controlled trial complemented with biosignal diary data to evaluate a newly developed system for work-related stress management and prevention for older adults (mHealthINX)

We hypothesise that mHealthINX will help lower stress in 50+ workers, as assessed both through pulse wave analysis & electrocardiogram analysis (i.e. biosignals captured through the hand-held SmartPWA3 developed by AIT) and self-reported…

The effect of long-term Momordica Charantia supplementation on blood glucose levels

We aim to assess the impact of 12-week BG supplementation on blood glucose levels in subjects with impaired fasting glucose levels.

IcoSApent ethyL to slow down aortic VAlve stenosis proGrEssion

This study has been transitioned to CTIS with ID 2024-517342-33-01 check the CTIS register for the current data. The primary objective is:• to study the effect of icosapent ethyl on progression of aortic valve calcification.The secondary objectives…

A randomised non-inferiority trial of esketamine versus electroconvulsive therapy in treatment-resistant depression

Phase 1:The primary objective of this trial is to investigate whether oral esketamine is non-inferior to ECT after eight weeks of individually optimized treatment, in participants with NTRD.Phase 2:To compare the efficacy of maintenance oral…

The added value of an internet-based intervention for treatment of aggression in forensic psychiatric outpatients

The primary objective of this study is to investigate whether the addition of the internet-based intervention *Aggression* to forensic psychiatric outpatient treatment as usual (TAU) results in better treatment outcomes in terms of self-reported…

Subcutaneous vedolizumab drug de-escalation using therapeutic drug monitoring in inflammatory bowel disease: a randomized controlled pilot study

This study has been transitioned to CTIS with ID 2024-517502-28-01 check the CTIS register for the current data. Our explorative pilot study wants to observe whether TDM can attribute to an efficient dose de-escalation strategy of SC vedolizumab in…

A randomized, double-blind, vehicle-controlled trial with safety run-in to assess the safety, tolerability and efficacy of DLQ02, a novel topical formulation Cyclosporine A (CsA), applied twice daily over four weeks to patients with plaque psoriasis.

To assess the safety, tolerability, pharmacodynamics and efficacy of two DLQ02 topical formulations in patients with plaque psoriasis. To assess systemic exposure of CsA and F6H8 after topical application.

Smartphone reported direct patient feedback on postoperative pain that is directly passed on to surgical ward nurses, effects on patient reported postoperative pain outcomes and pharmaco-therapy. A prospective, randomized, single-blinded, controlled trial.

To establish the effect of a smartphone application for direct patient feedback on patient reported postoperative pain outcomes and pharmaco-therapy in clinical patients.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of KBP-5074, a Mineralocorticoid Receptor Antagonist, in Subjects with Uncontrolled Hypertension Who Have Moderate or Severe (Stage 3b/4) Chronic Kidney Disease

The primary objective of this study is to evaluate the efficacy and durability of KBP-5074 in reducing SBP.The primary endpoint for efficacy is change in seated trough cuff SBP from baseline to Week 12.The second key endpoint for durability is…

Bariatric surgery Evaluation and Assessment of Treatment efficacy in heart failure and preserved ejection fraction - Intervention Trial

To evaluate the effects of a bariatric surgery strategy on clinical endpoints, cardiac parameters and functional status in patients with obesity (with BMI 32-40 kg/m2) and symptomatic HF with preserved or mildly reduced LVEF in combination with AF.

daNIS-3: An open-label, multi-center, phase II platform study evaluating the efficacy and safety of NIS793 and other new investigational drug combinations with standard of care (SOC) anti-cancer therapy for the second line treatment of metastatic colorectal cancer (mCRC)

Safety Run-in (SRI) part:To confirm the recommended phase 2 dose (RP2D) of NIS793 or any other investigational drug(s), in combination with SOC anti-cancer therapy. In protocol amendment 1, an arm with tislelizumab has been added. In this arm, the…