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SAMe as an epigenetic treatment of depression in people with childhood trauma, a double blind placebo-controlled trial

Primary objective is to compare changes in depression ratings in patients with childhood trauma receiving SAMe with patients receiving a placebo over a 12 week follow-up period. A number of secondary objectives will be investigated: 1. Comparing the…

Non-invasive vagus nerve stimulation in acute ischemic stroke.

The main objective will be to investigate whether treatment with nVNS on top of best medical practice in acute ischemic stroke patients results in smaller infarct volumes compared with the infarct volumes of patients not treated with nVNS.

A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Heterozygous Familial Hypercholesterolemia

Primary goal: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in children with heterozygous familial…

A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) that is Persistent or Recurrent Following BCG Induction (KEYNOTE-676)

This study has been transitioned to CTIS with ID 2022-501817-29-00 check the CTIS register for the current data. Cohort ATo compare the CRR for the combination of pembrolizumab + BCG versus BCG alone in participants with CIS.Cohort B- To compare the…

Effect of oral Eubacterium Hallii on postprandial glucose metabolism in males with type 2 diabetes treated with metformin

to investigate the effect of 14 days once daily oral Eubacterium hallii (E. hallii) treatment on postprandial glucose levels in relation to SCFA levels in feces in patients with type 2 diabetes treated with metformin.

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis

To test the hypothesis that mirikizumab is superior to placebo in maintaining clinical remission at Week 40 (Week 52 of continuous therapy) among patients induced into clinical remission with mirikizumab

Early detection of *silent* myocardial ischemia and cardiac dysfunction in asymptomatic individuals with increased coronary artery calcium scores

The aim of this study is to evaluate early silent myocardial ischemia detection and other parameters of cardiac dysfunction by cardiac MRI in asymptomatic high-risk individuals. We will study the prevalence and extent of early detected silent…

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

Anti-inflammatory effects of tiotropium in patients with stable COPD-A randomized controlled double-blind study

This research proposal aims to assess the anti-inflammatory effects after 6 weeks treatment with tiotropium compared to placebo in patients with stable COPD.

Effectiveness of mindfulness-based stress reduction for improving quality of life in patients with cardiovascular disease: a randomised controlled trial

In the Happy Hart study we investigate whether adding this mindfulness program to the standard treatment of people with cardiovascular diseases leads to a better quality of life, better mental health and a healthier lifestyle compared to the…

The (cost)effectiveness of neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine based chemoradiotherapy and adjuvant gemcitabine for (borderline) resectable pancreatic cancer.

This study has been transitioned to CTIS with ID 2024-516260-29-00 check the CTIS register for the current data. To determine whether neoadjuvant FOLFIRINOX followed by surgery improves overall survival and quality of life compared to neoadjuvant…

A Phase 1/1b First-in-human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR439459 Administered Intravenously as Monotherapy and in Combination with cemiplimab in Adult Patients with Advanced Solid Tumors

Primary Objectives:Dose escalation (Part 1)Part 1A (SAR439459 monotherapy)-To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with…

A phase I/II study of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) antibody-radionuclide-conjugate for treatment of relapsed non-Hodgkin lymphoma.

PART B (FL phase IIb *PARADIGME*):Primary objective:Randomised section of Part B- To evaluate the efficacy of the *40/15* dose regimen (40 mg lilotomab / 15 MBq/kg Betalutin) compared with *100/20* dose regimen (100 mg/m2 lilotomab/ 20 MBq/kg…

Improving the quality of life of patients with breast cancer-related lymphedema by lymphaticovenous anastomosis (LVA): A randomized controlled trial

The primary objective of this randomized controlled trial is to study the effectiveness of lymphaticovenous anastomosis (LVA) compared to complex decongestive therapy (CDT) in terms of health-related quality of life (HRQoL). Secondary objectives are…

Postoperative pain relief following pancreaticoduodenectomy: Triple P (PostPainPan) Study

- Primary objective: To compare the efficacy of postoperative pain treatments with sublingual sufentanil micro-tablets versus intravenous patient controlled analgesia with morphine or epidural analgesia in patients following pancreaticoduodenectomy…

A Phase II, Randomized, Open-label Platform Trial Utilizing a MastercProtocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants (study 205801)

Primary:To determine whether experimental regimens provide evidence for improved survival (randomization to death) over standard of care (SoC) therapy in NSCLC patients.Secondary:Milestone survival, measures of antitumor activity, safety and…

Internet-based WOrk-related cognitive Rehabilitation for Cancer survivors: a randomised controlled trial

The aim of the current study is to develop an internet-based cognitive intervention programme for occupationally active cancer survivors confronted with cognitive problems and to evaluate the (cost-)effectiveness of this programme.

Arterial oxygenation targets in mechanically ventilated patients in the intensive care unit, a randomized controlled triali

We have aimed to set up a new trial that will avoid these methodological flaws. It will be a study in 10-12 ICUs, using block randomization to decrease the risk of baseline imbalances. We will not stop the study prematurely for reasons other than…

Semaglutide effects on cardiovascular outcomes in people with overweight or obesity

The primary objective-To demonstrate that semaglutide 2.4 mg once weekly lowers the incidence risk of major adverse cardiovascular events (MACE) versus semaglutide placebo, both added to standard of care in patients with established CV disease and…

Home-based monitoring of ovulation to time frozen embryo transfer in IVF.

Assessing (cost-)effectiveness of home based monitoring with urinary LH tests (true natural cycle frozen embryo transfer, true NC-FET) versus hospital controlled monitoring with repeated ultrasound monitoring and hCG trigger (modified NC-FET) to…