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The use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams

Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied. Also other secondary endpoints will be evaluated.

Safety and protective efficacy of chemoprophylaxis and sporozoite immunization with Plasmodium falciparum NF135 against homologous and heterologous challenge infection in healthy volunteers in the Netherlands

Primary Objective: To determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxisSecondary Objectives:• To determine the dose-dependent protective efficacy of NF135.C10 CPS-immunization against homologous…

Pharmacokinetics of fosfomycin: a study in patients with prolonged treatment for urinary tract infection

The aim of this study is to evaluate and describe the PK of fosfomycin in individuals receiving oral treatment with multiple dosages of fosfomycin for recurrent and/or complicatedurinary tract infection. The results of this study will be used to…

A study examining the pharmacodynamic interaction between buprenorphine and fentanyl

* To determine if buprenorphine action at the MOR receptor can inhibit the respiratory depression response to IV fentanyl injection in healthy subjects and patients with chronic opioid use;* To determine if therapeutic concentrations achieved with…

A Phase IIa Open Label Single Arm Study of Safety and Efficacy of rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects

Primary Objective: To assess the safety of rVA576 in adult subjects with mild to moderate bullous pemphigoid (BP).Secondary Objectives: To assess the efficacy of rVA576 and its effect on the quality of life in adult subjects with mild to moderate…

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Cross-over Phase 2 Study of Continuous 5-Hour Intravenous Infusions of BMS-986231 in Patients with Heart Failure and Impaired Systolic Function

Primary* Evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to placebo. Secondary* Evaluate the effects of BMS-986231 on the left ventricular (LV)…

Optimal cerebral perfusion after an extracranial-intracranial bypass: should we increase blood pressure or cardiac output?

We aim to study what the mean change in graft flow rate is when the cardiac output is increased with 10% and what the mean change in graft flow rate is, when the blood pressure is increased with 10% to enable further research to establish whether an…

Intraoperative near-infrared (NIR) fluorescence imaging of the vascularization of the meniscus in patients treated with a total knee prosthesis * a pilot study

To explore the possibility of NIR fluorescence intra-operative angiography of the meniscus using ICG in patients undergoing total knee arthroplasty

An internet-based intervention for the prevention and early intervention of eating disorders: A randomized controlled trial investigating the effectiveness and cost-effectiveness of automatic feedback on self-monitored eating behaviour with or without weekly support from an expert patient.

The current study has two aims. Firstly, to investigate the effectiveness and cost-effectiveness of 8 weeks of the E-health program, Featback, in comparison to Featback with online support from an expert patient, online support from an expert…

A Phase 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab (SAR650984) in combination with atezolizumab or isatuximab alone in patients with advanced malignancies

Phase1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and…

Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis.

This study has been transitioned to CTIS with ID 2024-513538-40-02 check the CTIS register for the current data. To determine the value of quantitative whole body PET with [18F]PEG-Folate to predict development of clinical arthritis within one year…

Post-Market Clinical Investigation of the Clareon® IOL

Primary Objective:The primary objective of this study is to demonstrate the long-term (3 years) favorable visual acuity and adverse event outcomes for the Clareon IOL compared to historical SPE rates as reported in EN ISO 11979-7:2014.Secondary…

The effects of positive end-expiratory pressure on the position, length and function of the diaphragm

The objective of this study is to evaluate the acute effects of PEEP on the position, length, and contractibility of the diaphragm.

A 6-part first-in-human study of LOU064 consisting of a 4 part randomized, double-blind, placebo-controlled SAD and MAD study to investigate the safety and tolerability in healthy volunteers, subjects with atopic diathesis and subjects with atopic dermatitis, an open-label food effect study and a double-blind formulation effect study in healthy volunteers

To explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LOU064 over a treatment period of 4 weeks in a cohort of subjects with atopic dermatitis.

A randomized, open label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy

The primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.

The impact of genetic predisposition in pediatric renal cancer: genotypic and phenotypic characterization

1. To determine the frequency of mutations in known and novel pediatric renal cancer predisposing genes.2. To structurally document phenotypic characteristics of children with renal cancer, to optimize genetic counseling and surveillance and…

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…

HOT-REVA trial: Hyperbaric Oxygen Therapy for the treatment of RectoVaginal fistulas in Crohn*s disease.

To investigate the changes in fistula healing and quality of life after hyperbaric oxygen therapy in patients with Crohn's disease, and to assess the feasibility and safety of the treatment in these patients.

Clinical pharmacoloGy of platinUm-based hyperThermic intraperitoneal chemotherapy: exploration of the impact of flushing on tumOur, systemic and personnel eXposure

Primary objective:1. To explore the effect of flushing after HIPEC on tissue platinum exposureSecondary objectives:1. To explore the effect of flushing after HIPEC on wound exudate platinum concentration2. To explore the effect of flushing after…

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…