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Digital Cardiac Counseling Trial: DCC Trial

Pre-operative comprehensive digital Cardiac Counseling (prehabilitation) will reduce the cumalative incidence of MACE at 1 year postoperatively in patients operated for a cardiovascular procedure.

A Phase 1, Open-label, Single-dose, Randomized, Crossover Study to Assess the Local Tolerability of the Tildrakizumab 200 mg Dose when Delivered as Single Subcutaneous Injection via the 200 mg/2 mL Pre-filled Syringe

The purpose of this study is to investigate how well a new dosage form of tildrakizumab is tolerated when it is administered to healthy volunteers. Tildrakizumab (also known as Ilumetri) is no new compound; it is already available on the market as a…

Identification of sentinel lymph nodes in breast cancer patients through non-invasively and percutaneously fluorescent imaging using ICG

In this non-inferiority study, we aim to identify the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLN mapping versus the standard-of-care 99mTc in the SLN procedure for breast cancer patients.

Eating behaviors of Women with an Eating Disorder and Autism Spectrum Disorder

The goal of this study is to gain insight into the eating behaviors of women with an eating disorder (ED) and comorbid autism spectrum disorder (ASD). By comparing this group to two other groups (women with an ED but without ASD and women with an…

First in Human Study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PPSGG (PN-1007) in anti-MAG neuropathy patients.

Primary objectiveTo assess the safety and tolerability after single and multiple intravenous administrations of PPSGG in patients suffering from anti-MAG neuropathy.Secondary objectives- To evaluate the PK of PPSGG after single and multiple…

Randomized, Blinded, 2 stage, 2-way Crossover Bioequivalence Study of Mentholatum 10% w/w Ibuprofen Gel and Ibuleve 10% w/w Ibuprofen Gel Administered as a Single Application of 125 mg in Healthy Subjects

This study will compare the study compound Mentholatum 10% w/w Ibuprofen Gel to a similar product, which is already on the market in UK called Ibuleve Maximum Strength Gel. The purpose of the study is to compare these two gels in how quickly and to…

Effects of IVF culture conditions on the embryonic genome, methylome and transcriptome: a study to evaluate the safety and quality of different culture systems

To study the effects of in vitro culture conditions, such as different culture media or oxygen tension, on omic layers (i.e. genome, epigenome and transcriptome) of preimplantation human embryos and to relate this to chromosoom instability (CIN).

A MULTICENTRE, SAD, AND MAD CLINICAL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF IV TREATMENT OF CALY-002 IN HEALTHY SUBJECTS AND SUBJECTS WITH COELIAC DISEASE AND EOSINOPHILIC OESOPHAGITIS

The objectives of Part B of the study are as follows: Primary: To assess the safety and tolerability of CALY-002 following multiple ascending doses administered IV in subjects with coeliac disease (CeD). Secondary: (1) To characterise the PK of CALY…

Neo-adjuvant nivolumab or nivolumab with ipilimumab in advanced cutaneous squamous cell carcinoma patients prior to standard of care surgery; the MATISSE trial

Herewith, we present a research protocol for a phase II trial that allows us to examine the efficacy (histopathological response rate) of ICI in the form of nivolumab or nivolumab plus ipilimumab prior to SOC in patients with resectable stage III-…

A PHASE I/II, MULTICENTER, OPEN-LABEL, MULTI-ARM STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY ACTIVITY OF IDASANUTLIN IN COMBINATION WITH EITHER CHEMOTHERAPY OR VENETOCLAX IN THE TREATMENT OF PEDIATRIC AND YOUNG ADULT PATIENTS WITH RELAPSED/REFRACTORY ACUTE LEUKEMIAS OR SOLID TUMORS.

This study will evaluate the safety, tolerability, and pharmacokinetics of idasanutlin as a single agent and the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin in combination with either chemotherapy or venetoclax in…

A randomized clinical trial to evaluate the efficacy of polyethylene glycol vs psyllium fiber to prevent rebleeding in patients hospitalized with bleeding diverticular disease.

To evaluate the efficacy of laxatives (polyethylene glycol) versus supplementation of fibers on the incidence of rebleeding in patients hospitalized for colonic diverticular bleeding.

B-Fine: An open label, single arm study to mechanistically interrogate the therapeutic effect of GSK3228836 in patients with Chronic Hepatitis B via intrahepatic immunophenotyping

Primary objective:To assess the effect of 12 weeks of GSK3228836 on serum hepatitis B virus surface antigen (HBsAg) levels in participants with CHBSecondaryEfficacy: To assess sustainability of serum HBsAg loss by GSK3228836 for up to 24 weeks off-…

Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

This study has been transitioned to CTIS with ID 2024-511743-26-00 check the CTIS register for the current data. Primary Objective: Major amputation rate after 12-months of follow-upSecondary Objectives: - Amputation-free survival- Health-related…

Role of genomic factors on late adverse events after lymphoma

Our main objective is to dissect the genomic determinants of treatment-related adverse events after lymphoma, specifically cardiovascular disease and second malignant neoplasms. As such, we will assess the association of genetic and epigenetic…

Suicidal ideation Assessment: Fluctuation monitoring with Ecological momentary assessment

This is the first study to combine both objective and subjective daily measures (EMA and actigraphy) to assess fluctuations in suicidal ideation, in real time and in natural settings. The aims of the study are (1) to examine how momentary risk and…

A PHASE 3, RANDOMIZED, DOUBLE-BLINDED,
PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND
SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F
SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING
PREGNANCY
Short title: A Phase 3 Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

to assess the efficacy, safety, and immunogenicity of bivalent RSVpreF or placebo (1:1 randomization) in infants born to healthy women vaccinated during pregnancy, as well as the safety and immunogenicity in the pregnant women.

A randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitis

To evaluate the efficacy based on the histological response

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

This study has been transitioned to CTIS with ID 2023-506873-36-00 check the CTIS register for the current data. The primary objective of this study is: Part 1: To evaluate the efficacy of AL001 compared with placebo as measured by CDR® plus NACC…

A multi-center, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CK-3773274 in adults with symptomatic hypertrophic cardiomyopathy

Primary objectives:To determine the safety and tolerability of CK-3773274 in patients with symptomatic HCMSecondary objectives:- To describe the concentration-response relationship of CK-3773274 on the resting and post-Valsalva LVOT-G on…

Non-invasive fetal electrocardiography and speckle tracking echocardiography in the second trimester, 16 until 28 weeks gestational age: a prospective cohort study.

The primary objective of this study is to generate reference values for NFMS parameters as well as for 2D-STE parameters during the second trimester, 16 until 28 weeks gestational age. The secondary objective is to investigate the diagnostic…