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A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.

Primary Objective: To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD attack in subjects with NMO/NMOSD.Secondary Objectives:1. To compare the efficacy of MEDI-551 versus placebo on the reduction of EDSS…

Study to clinically evaluate the QT/QTc interval prolongation potential of vericiguat in patients with stable coronary artery disease in a 2-arm, placebo-controlled, randomized, double-blind, double-dummy design including a vericiguat multiple-dose part with fixed up-titration periods and moxifloxacin as positive control (for assay sensitivity testing, nested into the placebo treatment)

The objective of this study is to evaluate the effect of multiple doses of vericiguat on the QTcinterval in patients with stable CAD10 within the exposure range observed in Phase II/IIIstudies:Primary objective:* To investigate whether there is a…

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ISIS 416858 (IONIS-FXIRX an Antisense Inhibitor of Factor XI), Administered Subcutaneously to Patients with End-Stage Renal Disease on Hemodialysis

Primary objectives: To evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ISIS 416858 (200, 250, and 300 mg once weekly) as compared to placebo.Exploratory Objectives: Incidence of myocardial infarction (MI), stroke, systemic…

Growing up with X and Y chromosome trisomy: the TRIXY study

The aims of this study are to1) To identify information processing deficits that can help explain predict communication impairments, language deficits, social problems and increased risk for psychopathology.2) To assess if lack of regulation of…

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis

To investigate efficacy of ASP6294 in female subjects with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC).To investigate safety and tolerability of ASP6294 in female subjects with BPS/IC.To investigate the pharmacokinetics and pharmacodynamics…

Sedation with propofol TCI during ERCP: Is the combination with esketamine more effective and safer than with alfentanil (SPEKA): A randomized controlled multicentre trial

The aim of this study is to demonstrate that procedural sedation with propofol and esketamine is more effective and will result in less cardiopulmonary depression than sedation with propofol and the opioid alfentanil. Less side effects should also…

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects with Severe Sepsis and Coagulopathy.

The primary objectives of this study are:• To determine whether ART-123, when administered to subjects with infection complicated by at least one organ dysfunction and coagulopathy, can reduce mortality.• To determine the safety of ART-123 in this…

Core elements of Cognitive Behavioral Therapy in preventing depression in youth:
Does the type and sequence of elements matter?

The primary objective is to investigate whether (and if so, which) type of CBT-element (cognitive restructuring (CR), behavioral activation (BA), relaxation (RE) and problem solving skills(PS)) is relevant for the positive effect of CBT-programs on…

Less injections by androgen scrutinisation

The primary objective of this study is to determine the possibility to extend the dosing interval of goserelin 10.8 mg with a testosterone-based dosing regimen compared to regular treatment with 3-monthly based goserelin 10.8 mg injections. This…

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of DNL104 in Healthy Subjects

* Investigate the safety and tolerability of multiple ascending oral doses of DNL104 in healthy subjects* Characterize the pharmacokinetics (PK) of DNL104 in plasma and measure the trough concentrations of DNL104 in CSF* Explore the pharmacodynamics…

Effectiveness of Somatostatin Analogues in Patients with hereditary hemorrhagic telangiectasia and symptomatic gastrointestinal bleeding, the SAIPAN-trial: a multicenter, randomized, open-label, parallelgroup, superiority trial.

To determine if SSA are effective in decreasing transfusion requirements and improving quality of life while being cost-effective.

Roads to Recovery, control of balance and gait after stroke

The primary objective of this study is to compare the changes in neuromuscular control related to reactive and adaptive movements during balance and gait, following Dynamic C-mill Training to conventional physiotherapy. Furthermore, an additional…

US-guided Percutaneous needle tenotomy in Patients with Lateral Elbow Tendinopathy: A multicenter Randomized Controlled Trial

To study the effect of PNT and structured exercises on function and pain of patients with lateral elbow tendinopathy.

Randomised controlled trial of the effects of cognitive behavioral therapy for insomnia on sleep, impulsivity and aggression in forensic psychiatric patients

Evaluating the effects of cognitive behavioral therapy for chronic insomnia (CBT-I) on sleep, general psychopathology, impulsivity and aggression in forensic psychiatric patients.

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients with Heart Failure and Impaired Systolic Function

Primary Objective:The primary objective is to evaluate the effects of various doses of BMS-986231 compared to placebo on clinically relevant hypotension (defined by SBP < 90 mm Hg or symptoms of hypotension)Secondary Objectives:* Assess the…

Phase shift in adult ADHD of sleep and apetite.

In this study the best treatment of DSPS will be investigated by comparison of existing treatments. We will investigate is patients with ADHD and DSPS have less favorable blood values for biomarkers of chronic diseases in comparison with norm values…

A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure

Despite continuous improvements in the medical management of pediatric patients with CHD, the risk of thrombotic events remains an important complication for pediatric patients following the Fontan procedure.The National Heart, Lung and Blood…

A Phase 2a Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Parallel Group, Dose-Range Finding Study of MVT-602 in Healthy Premenopausal Women Undergoing Controlled Ovarian Stimulation (COS) Using a Minimal Stimulation Protocol.

To characterize the exposure-response relationship of MVT-602 effects on luteinizing hormone (LH) concentrations after subcutaneous administration of single 0.1 to 3 µg doses of MVT-602 or placebo in healthy premenopausal women undergoing COS to…

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects with Moderate to Severe Hidradenitis Suppurativa

Primary ObjectiveThe primary objective of this study is to evaluate the initial efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).Secondary ObjectivesThe secondary objectives…

Immunisation, Treatment and Controlled Human Hookworm Infection

Primary objective:* To determine the protective efficacy of repeated short term exposure to hookworm infection Secondary objectives:1. To explore the immunological response after repeated hookworm infections2. To evaluate the safety of and number of…