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A Phase II Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of VS 6063 in Subjects with Malignant Pleural Mesothelioma

Primary Efficacy Objectives• To compare the overall survival (OS) in subjects with malignant pleural mesothelioma receiving VS-6063 or placebo.• To compare the progression free survival (PFS) in subjects with malignant pleural mesothelioma receiving…

Vitamin D treatment effect on retinal nerve fiber loss after optic neuritis

Primary objective:- To determine whether high dose vitamin D treatment in optic neuritis can reduce axonal loss as measured by OCT. Secondary objectives: - To investigate whether the occurrence of a second attack (defining clinically definite MS) is…

Combining N-of-1 trials to estimate population clinical effectiveness of drugs using Bayesian hierarchical modeling. The case of Mexilitin for patients with Non-Dystrophic Myotonia.

(voor meer details zie CMO-protocol paragraaf 2: Objectives) Primary Objective: The objective of this project is to further refine N-of-1 trial methodology, and explore whether Bayesian analysis of multiple N-of-1 trials can serve as a sufficient…

A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder

Subjects randomized to the placebo treatment are unlikely to benefit from the study. However, OAB is not a life-threatening disease and it is not expected that a 12 to 15 week exposure to placebo treatment will have a negative impact on disease…

A Phase 2A, Double-blind, Placebo-controlled, Randomized
Study to Evaluate the Safety and Efficacy of TRC150094 in Increasing Insulin Sensitivity in Male patients with increased Cardiometabolic Risk

To determine the safety and efficacy (in increasing insulin sensitivity) of TRC 150094 once daily dosing for 4 weeks in male subjects with increased cardiometabolic risk.To evaluate the effect of TRC150094 on hepatic fat and metabolic parameters.To…

First International Randomized Study in MAlignant Progressive Pheochromocytoma and Paraganglioma

Primary objective: To determine the efficacy of Sunitinib on the progression-free survival at 12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated with sunitinib at a starting dose of 37.5 mg daily (continuous…

Attention Defficity Hyperactivity Disorder and fMRI neurofeedback: A randomized controlled trial on the effects of self-modulating anterior cingulate cortex activation levels.

The principal objective of this study will be to critically evaluate if the fMRI-neurofeedback training is successful in reducing ADHD symptoms and improving cognitive functioning. Thus, the first goal is to show that ADHD patients are able to…

A randomised sequential trial of Lithium in amyotrophic lateral sclerosis

To determine the effect of lithium treatment (plasma levels between 0,4-0,8 mEq/liter) versus placebo - in addition to riluzole 2dd 50 mg - on reaching a clinical endpoint in patients with ALS.

Ultrasound contrast agents to facilitate sonothrombolysis in patients with acute myocardial infarction

Primary objective: Can application of diagnostic ultrasound and microbubbles enhance epicardial coronary recanalization with a lower and safer dose of a thrombolytic agent such as alteplase 50mg when combined with normal care consisting of prasugrel…

The effect of intradialytic supplementation in chronic hemodialysis patients; a pilot study

The primary objective of this pilot study is the feasibility of prolonged intra-dialytic creatine supplementation. The secondary objectives of this pilot study are to study the safety of prolonged intra-dialytic creatine supplementation for dialysis…

A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjögren*s Syndrome

To determine the dose-response relationship of VAY736 for key efficacy and safety parameters.

A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects with Active Crohn*s Disease (Serenity)

Primary objective: To test the hypothesis that treatment with LY3074828 is superior to placebo in the proportion of subjects with endoscopic response at Week 12, defined as 50% reduction from baseline in SES-CD ScoreSecondary objective: • To…

ERtugliflozin triAl in DIabetes with preserved or reduced ejeCtion FrAcTion;mEchanistic evaluation in Heart Failure: "ERADICATE-HF"

The systematic understanding of the effects of SGLT2i in the setting of HF will enable the design of rational physiology based strategies to decrease the burden of HF, which could have major clinical and research implications internationally.

Efficacy and safety of NNC6019-0001 at two dose levels in participants with
transthyretin amyloid cardiomyopathy (ATTR CM)

This study has been transitioned to CTIS with ID 2023-506824-96-00 check the CTIS register for the current data. • safety and tolerability from baseline to week 64 in participants with hATTR or wtATTR cardiomyopathyPrimary • To compare the effect of…

Alkaline Phosphatase as treatment of Ischemia Reperfusion Injury to prevent delayed graft function in deceased donor kidney transplantation

This study has been transitioned to CTIS with ID 2024-515480-66-01 check the CTIS register for the current data. To attenuate the impact and duration of delayed graft funtion by dampening schemia reperfusion injury

Synbiotics and Conditioned Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis.

Primary objective To investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and FOS with and without conditioned vegan LFMT capsules to reduce NASH in patients with fibrotic NASH…

Anakinra: safety and efficacy of interleukin-1 pathway inhibitor anakinra for the management of fever during neutropenia and mucositis in patients with multiple myeloma receiving an autologous hematopoietic stem cell transplantation after high-dose melphalan - A randomized controlled trial

The primary objective is to evaluate the efficacy of anakinra in patients with multiple myeloma receiving high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (SCT). The primary endpoint is the…

Stratified Treatment to Ameliorate Diastolic left ventricular stIffness in eArly Heart Failure with preserved Ejection Fraction (STADIA-HFpEF)
A 35-week, single-center, prospective, double-blind, controlled, randomized, 2x2 crossover, interventional Phase II study, investigating the effect of treatment with dapagliflozin 10mg od on Left Ventricular distensibility in patients with early HFpEF.

The primary objective is to assess in a 2x2 crossover design, whether compared to placebo dapagliflozin 10 mg od for 13 weeks improves LV distensibility, measured with echocardiography in patients with early HFpEF (LVEF >= 50%), defined as…

An explorative study for halting inflammation in patients with emphysema by administration of allogeneic bone marrow derived mesenchymal stromal cells.

Development of mesenchymal stromal cell therapy to halt the progression of emphysema.

A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn*s disease with an option for open-label treatment extension (CALDOSE-2)

Primary objective• To determine the optimal dose of IMU-838 to induce symptomatic remission (based on stool frequency [SF] and abdominal pain [AP], as assessed in the Crohn*s Disease Activity Index [CDAI] patient reported outcome [PRO]-2) in…