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Randomized, double-blind, triple-dummy trial to compare the efficacy of otamixaban with Unfractionated Heparin + eptifibatide, in patients with Unstable angina/Non ST segment Elevation Myocardial infarction scheduled to undergo an early invasive strategy

Primary: To demonstrate the superior efficacy (composite of all-cause death + Myocardial infarction) of otamixaban to unfractionated heparin (UFH) + eptifibatideSecondary:• To demonstrate the superior efficacy ( composite of all-cause death +…

Effects of oral corticosteroids and DMSO on inflammatory signs and symptoms in Complex Regional Pain Syndrome type 1

In this trial we will study if treatment with oral corticosteroids or DMSO is effective in decreasing signs and symptoms of CRPS-1. Tolerance of the treatment options and effects on different subtypes of CRPS-1 patients will be evaluated as well.

Metacognitive therapy vs. exposure and response prevention for obsessive-compulsive disorder: A randomized clinical trial.

The present trial is initiated to compare the effectiveness of MCT with ERP, the current treatment of choice for OCD, in an outpatient clinical sample of patients with OCD. The following hypothesis is formulated: MCT is more effective than ERP, both…

ProtEUs: Effects of an infant formula with an optimized amino acid composition on growth and body composition in infants

To assess the effect of an infant formula with an optimized amino acid composition and a lower total protein content during the first four months of life on infant growth. Amendment follow-up study: To assess the long term effect of the intake of an…

Phase III Randomized Double-Blind Trial of Bepanthen® Cream Versus Cetomacrogol Cream in the Prevention of Papulopustular eruption in Patients Receiving Epidermal Growth Factor Receptor Inhibitors (EGFRI): BeCet

To assess the preemptive effect of Bepanthen® on decreasing the incidence of specific >= grade 2 dermatological side effects of interest in respect of compliance to EGFRI agents, HRQoL and the adherence during the 6-week skin treatment period…

Adrenaline use in local infiltration analgesia during TKA;Randomized, double blind, controlled study

The goal of the pilot study is to compare LIA with or without adrenaline infiltration by means of post operative pain (VAS) scores, PONV, early mobilisation and early discharge criteria.

Computer based cognitive flexibility training after stroke

In this study the effectiveness of online cognitive flexibility training on cognitive functioning in stroke patients will be investigated. The aim of this study is to improve executive functions: both trained executive functions as well as untrained…

Morphine versus piritramide (Dipidolor??) in postoperative analgesia. Time of onset of analgesia and incidence of postoperatieve nausea and vomiting after intravenous injecttion. A comparison.

The investigation of differences between morphine and piritramide concerning the incidence of postoperative nausea and vomiting and the time of onset of adequate analgesia.

A randomized controlled trial on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth

In the proposed study, two main issues will be addressed: first, it will be studied whether a high dose (4.0 mg) of FA supplementation periconceptional has an added value over the now recommended low dose of 0.4 mg in the prevention of congenital…

Fecal Microbiota Transplantation to Restore Residual Beta Cell Function In Patients With Long-Duration Type 1 Diabetes Mellitus

To investigate whether fecal microbial transplantation (FMT) from either allogenic (individuals with type 1 diabetes and a highly preserved beta cell fraction) or autologous (own) donor, administered every 8 weeks during 6 months through a small…

A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled
Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects with Moderate to Severe Atopic Dermatitis.

The objective of this study is to evaluate the efficacy and safety of upadacitinib versus dupilumab for the treatment of adult subjects with moderate to severe atopic dermatitis who are candidates for systemic therapy.

A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine given as a series of 2 infant doses and 1 toddler dose in healthy infants

Primary Safety Objective: To describe the safety profile of 20vPnC

Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg in Subjects with Previously Untreated, Unresectable or Metastatic Melanoma

Primary Objective:The primary objective is to compare the incidence of drug-related Grade 3 - 5 AEs of N3I1 to N1I3 in subjects with previously untreated, unresectable or metastatic melanoma.Secondary Objective:• To evaluate the ORR, as determined…

Evaluation of a novel alternative protein source to stimulate post-exercise muscle protein synthesis

From p11 of C1 protocol document:1) To define the characteristics of mealworm protein ingestion on protein/digestion absorption kinetics and both whole-body and myofibrillar muscle protein synthesis after a single bout of resistance exercise in…

ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

To evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain and no prior spine surgery when used in conjunction with medical management.

A Randomized, Double-blind, 2-Way Crossover Bioequivalence and Adhesion Study of a Transdermal Contraceptive Patch Manufactured with Newly Sourced Adhesive Components at the End of Shelf Life and Currently Marketed EVRA® at the Beginning of Shelf Life in Healthy Adult Women

Main objective:To determine the bioequivalence of the hormones (ie, NGMN and EE) from the transdermal contraceptive patch using the newly sourced adhesive component N100 at EOSL as compared to the currently marketed EVRA patch using the adhesive…

A phase 3, randomized, double-blind trial of nivolumab in combination with intravesical BCG versus standard of care BCG alone in participants with high-risk non-muscle invasive bladder cancer that is persistent or recurrent after treatment with BCG

Primary objectiveTo compare the event free survival per pathological review committee (PRC) of nivolumab plus BCG vs BCG alone in all randomized ParticipantsEFS, defined as the time from randomization until any of the following events: recurrence (…

The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study

Primary objectiveTo compare the effect on pulmonary vascular resistance (PVR) of an initial triple oral regimen (macitentan, tadalafil, selexipag) versus an initial dual oral regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-…

A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of NeoGAA (GZ402666) and Alglucosidase Alfa in Treatment naïve Patients with Late-onset Pompe Disease

The overall objective of this study is to evaluate the efficacy and safety of neoGAA in treatment-naïve patients with LOPD as compared to alglucosidase alfa, when this is administered biweekly for a period of 49 weeks. Also, there is an open-label…

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

The objective is to evaluate safety and efficacy of higher induction and maintenance dosing regimens in subjects with moderately to severely active Ulcerative Colitis (UC).