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A prospective, lead-in study to collect bleeding episodes, Factor VIII (FVIII) infusions, and patient-reported outcomes in patients with hemophilia A

This is a so-called *lead-in study* in which patients receive their standard treatment and no study treatment. The researchers will collect dataabout the patients* bleeding episodes, FVIII containing treatments used to prevent bleeding episodes and…

A phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, of oral FT011 in participants with diffuse systemic sclerosis

Primary objective: To assess the PK of oral FT011 in participants with diffuse SSc.Secondary objectives: • To assess the safety and tolerability of oral FT011 compared to placebo in participants with diffuse SSc.• To evaluate the short-term efficacy…

A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)

PART A and PART DTo assess the safety and tolerability of TAK-994 following multiple oral doses in subjects with narcolepsy with or without cataplexy (NT1 or NT2).PART B and PART C To assess the efficacy of TAK-994 on reducing excessive daytime…

A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT)

Rationale:The aim of this study is to investigate the pharmacodynamics (PD), pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20)…

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…

Personal protein digestion variability

Primary Objective: To quantify the variation in post-prandial plasma AA profiles between (and within) individuals after consumption of a poorly digestible plant protein source (lucerne). Secondary Objective: To compare the variation in postprandial…

An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Functional Mitral Regurgitation

The objective of this prospective, multi-center trial is to assess the effectiveness of the Carillon Mitral Contour System in treating patients with moderate-to-severe atrial functional mitral regurgitation (aFMR).

Immune profiling of tumor and blood of patients with nasopharyngeal cancer

To determine local and systemic immune markers, with emphasis on T lymphocytes, in primary and recurrent NPC patients and investigate how these immune markers correlate to clinical response to CR in NPC. Primary Objective1:Profile whole blood and…

Defining type 2 asthma phenotypes based on clinical, biological and functional parameters using cluster analysis.

The main objective is to investigate the heterogeneity of type 2 asthma by identifying phenotypes by means of cluster analysis. Secondary, the clinical interpretation of these clusters is investigated.

Can early glasses prevent the development of amblyopia in children with high refractive errors at age one?

To investigate whether treating children with high refractive errors at age one with glasses prevents the development of amblyopia.

Intra-articular injection of adipose-derived stromal vascular fraction in osteoarthritis of the temporomandibular joint

The main objective of this study is to test the hypothesis that SVF alleviates pain and increases maximal interincisal mouth opening in patients with TMJ osteoarthritis.

Optimising screening for early disease detection in familial pulmonary fibrosis

Our primary objective is to determine the prognostic value of parameters for early disease detection of familial pulmonary fibrosis in the study population. All putative parameters for detection of preclinical disease have been shown to be…

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…

In vitro potency of clinically used antiplatelet drugs in patients with Metabolic dysfunction Associated Fatty Liver Disease

To compare the in vitro potency of commonly used antiplatelet drugs in the blood of patients with various stages of fibrosis due to MAFLD, compared to that in blood of individuals without underlying liver disease.

A randomised double-blind placebo-controlled clinical trial investigating the effect and
safety of oral semaglutide in subjects with early Alzheimer*s disease (EVOKE plus)

This study has been transitioned to CTIS with ID 2023-506918-45-00 check the CTIS register for the current data. Primary objectiveTo confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with…

The prognostic value of occult peritoneal tumor cells, detected by ddPCR for KRAS, in patients with (borderline) resectable pancreatic cancer

To add 36 benign control patients to the Expect study to investigate whether detection of a KRAS mutation by ddPCR in peritoneal fluid is truly specific for pancreatic cancer.

Prospective, Multicenter, Post-market, Single Arm study to confirmthe performance of the RenzanTM Peripheral Stent System in treating Superficial Femoral and/or Popliteal artery disease

Primary objective: To confirm the safety and efficacy of the RenzanTM Peripheral Stent System when used for treatment of superficial femoral (SFA) and/or popliteal (POP) artery disease.Secondary objective: Assessment of the primary patency of the…

Management of psoriasis and risk and severity of COVID-19 infection in systemic, biologic and topical treatment for psoriasis during the COVID-19 pandemic: an epidemiological cohort study

Evaluate the point-prevalence, relative risk and severity of COVID-19 infections in psoriasis patients treated with immunosuppressive biologicals or conventional systemic immunosuppressive therapies as compared to topical treatments. Furthermore, we…

Medical hypnosis with VR glasses to reduce pain and anxiety during needle related procedures in children

The aim of the study is to measure the effect on pain during needle-related procedures using VR hypnosis glasses versus hypnosis by a health care professional. Secondarily, anxiety, blood pressure, heart rate and patient satisfaction are measured.

A phase 3 extension trial of DELTA 1 and DELTA 2 to evaluate the long-term safety of a twice-daily treatment with delgocitinib cream 20 mg/g as needed for up to 36 weeks in adult subjects with chronic hand eczema (DELTA 3)

Primary objective:To evaluate the long-term safety of an as-needed treatment with twice-daily applications of delgocitinib cream 20 mg/g.Secondary objective:To evaluate the long-term efficacy of an as-needed treatment with twice-daily applications…