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Excitatory/Inhibitory imbalance in autism spectrum disorder

To define a link between excitatory/inhibitory (glutamate/GABA) neurotransmission and neural functioning across different brain regions (regional specificity) and to establish the relation between this link and ASD symptomatology (tapping into…

PROTECTED TAVR: Stroke PROTECTion with SEntinel During Transcatheter Aortic Valve Replacement

The objective of this study is to demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of periproceduralstroke (*72 hours) after transcatheter aortic valve replacement (TAVR).

A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Primary:To compare the efficacy of abrocitinib 200 mg once daily (QD) versus dupilumab (as per label guidelines) in adult participants on background topical therapy with moderate to severe atopic dermatitis (AD).Key SecondaryTo compare the efficacy…

Standard re-ablation versus advanced HD mapping guided ablation in recurrent symptomatic atrial fibrillation or atrial tachycardia after initial pulmonary vein isolation

To determine the clinical effectiveness of HD mapping guided tailored ablation as compared to standard re-ablation that targets PV reconnection and antral tissue only in patients with symptomatic AF or AT requiring re-ablation after initial PVI.

A randomized, double-blind, placebo-controlled, single ascending dose study to examine the safety, tolerability and pharmacokinetics of orally administered PHA-022121 in healthy subjects.

Primary ObjectiveTo assess the tolerability and safety of single ascending oral doses of PHA-022121 administered after a standard meal and of a single 40 mg dose under fasted conditions in healthy adult subjects.To assess the PK characteristics of…

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of EDP-938 Administered Orally for the Treatment of Acute Upper Respiratory Tract Infection with Respiratory Syncytial Virus in Ambulatory Adult Subjects (RSVP)

Primary Objective• To evaluate the effect of EDP-938 on the progression of RSV infection by assessment of clinical symptomsSecondary Objectives• To evaluate the antiviral efficacy of EDP-938• To evaluate the pharmacokinetics (PK) of EDP-938• To…

Optimizing lifestyle behaviors in women at high risk for pregnancy complications and their partners before and in early pregnancy by combining personalized eHealth & Face-to-face coUnSEling.

To study if a blended personalized periconception lifestyle care approach aimed at women with a high risk for pregnancy complications who are contemplating pregnancy or already pregnant (*12 weeks) can significantly reduce Lifestyle Risk Score.

A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Are Naïve to Biologic DMARD Therapy

The primary objective of this study is:* To evaluate the effect of filgotinib compared to placebo in active psoriatic arthritis (PsA) as assessed by the American College of Rheumatology 20% improvement (ACR20) response at Week 12Secondary objectives…

Continuous low dose subcutaneous lidocaine for treatment of pneumonia in COVID*19 patients.   A randomised controlled (RCT) open*label phase III study.

The disappearance of the main symptoms of the COVID*19*induced pneumonia within 5 days after the initiation&…

Bronchodilators for wheeze in young children presenting to primary care: a randomised, placebo-controlled, multicentre, parallel group trial.

What is the (cost-)effectiveness of salbutamol inhalations (4x200*g for 7 days) versus placebo in children aged 6-24 months presenting to their primary care physician with wheezing?

A 12-week, multi-center, double-blinded, parallelgroup, randomized, placebo-controlled phase IIb study to evaluate the safety, tolerability and efficacy of IZD334 to reduce CRP in cardiovascular high-risk patients.

To evaluate the safety, tolerability and efficacy of IZD334 to reduce CRP in cardiovascular high-risk patients.

Beta-alanine supplementation in patients with COPD receiving non-linear periodized exercise (NLPE) training: randomized placebo-controlled trial.

The primary objective is to compare the effects of daily beta-alanine supplementation or a placebo supplement on exercise tolerance (walking endurance time) in patients with COPD receiving NLPE.The secondary objectives are:• to determine the effects…

Magnetic non-Invasive acupuncture for Infant comfort during retinopathy of prematurity examination

To investigate whether non-invasive ear magnetic acupuncture will help reduce pain and stress for preterm infants in the Neonatal Intensive Care Unit (NICU) during their routine eye examination for Retinopathy of Prematurity (ROP).

A randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of BAY 2327949 in patients with chronic kidney disease (eGFR range from 25 to 60 mL/min/1.73 m²) due to type 2 diabetes or hypertension and at least one cardiovascular comorbidity

To evaluate the efficacy of BAY 2327949 to decrease urine albumin-to-creatinine ratio (UACR) in patients with chronic kidney disease.To evaluate the safety and tolerability of BAY 2327949.

An open label, randomized Phase II study of BI 754091 alone or in combination with BI 836880 in patients with chemotherapy resistant, unresectable, metastatic squamous cell carcinoma of the anal canal

The objective of this trial is to assess anti-tumour activity of BI 754091 as a monotherapy and of BI 754091 in combination with BI 836880 in patients with unresectable or metastatic squamous cell carcinoma of the anal canal who progressed on or…

'A phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose intravenous and subcutaneous administration and multiple-dose subcutaneous administration of OMS906 in healthy subjects'

The purpose of this study is to investigate how safe the new compound OMS906 is and how well it is tolerated when it is administered to healthy volunteers. OMS906 has not been administered to humans before. It has been previously tested in the…

A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Primary:* To demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment in study participants with primary ITPSecondary:* To assess the safety and tolerability of rozanolixizumabExploratory:* To evaluate the clinical efficacy as…

TriGUARD 3 TransCranial Doppler (TCD) Ultrasound Study: A prospective, randomized, real-time evaluation of blood filtration with the TriGUARD 3 Embolic Protection Device Using TCD During Transcatheter Aortic Valve Implantation (TAVI).

To demonstrate that the Cerebral Embolic Protection Device (TriGUARD*3) in patients undergoing Transcatheter Aortic Valve Implantation (TAVI) leads to less brain injury as assessed by transcranial Doppler measurements.

Continuous low dose subcutaneous lidocaine for treatment of the symptoms of COVID*19.   A randomised controlled open*label phase III study.

To determine the effect of lidocaine on the main symptoms of COVID-19.

RE-DUAL PCI Real life Registry: Dual Therapy with dabigatran/clopidogrel versus Triple Therapy with dabigatran/clopidogrel/aspirin in ACS patients with indication for NOAC undergoing PCI.

A real world registry to compare dual therapy with Dabigatran/Clopidogrel to Usual care (Triple Therapy) with Dabigatran/Clopidogrel/Aspirin in patients with an indication for NOAC undergoing PCI in the setting of ACS. Hypothesis: Dual therapy with…