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A placebo-controlled double blind randomized trial to investigate the efficacy and safety of the combination of Penicillin G / Hydrocortisone treatment in ALS patients (PHALS).

The objective is to compare the efficacy and safety of intravenous high-dose penicillin G and hydrocortisone versus placebo in combination with riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).

A phase 2, double-blind, randomized, placebo-controlled pharmacokinetic trial in two parallel groups to investigate possible drug- drug interactions between stiripentol or valproate and GWP42003-P in patients with epilepsy.

Primary Objective: To determine whether GWP42003-P affects the pharmacokinetic (PK) profile of stiripentol (STP) or valproate (VPA).Secondary Objective: To assess the safety and tolerability of GWP42003-P in the presence of STP or VPA.To assess…

Umbilical cord blood transplantation in high-risk hematological patients using stemregenin-1 expanded hematopoietic stem cells.
A feasibility study focussing on engraftment and hematopoietic recovery.

To study the feasibility of single UCBT with one ex-vivo SR-1 expanded unitTo assess side effects and TRM after single UCBT with one expanded unitTo assess engraftment and engraftment kinetics; to evaluate immune reconstitution, acute and chronic…

A randomised sequential trial of Lithium in amyotrophic lateral sclerosis

To determine the effect of lithium treatment (plasma levels between 0,4-0,8 mEq/liter) versus placebo - in addition to riluzole 2dd 50 mg - on reaching a clinical endpoint in patients with ALS.

Safety and efficacy of interleukin-1 inhibitor anakinra for the amelioration of fever during neutropenia and mucositis in patients with multiple myeloma receiving an autologous hematopoietic stem cell transplantation after high-dose melphalan

The primary objective is to evaluate the safety and efficacy of anakinra in patients with multiple myeloma receiving high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (SCT). Secondary objectives…

Explorative trial to identify the impact of denosumab on the systemic immunity and local immunologic microenvironment in postmenopausal patients with HER2 negative breast cancer.

Primary objective• Determine the change in intratumoral T-cell (CD4, CD8 and Treg) and Myeloid cell (M1/M2 Macrophage, MDSC, DC) numbers and function between the baseline biopsy and the surgical specimen.Secondary objectives• PBMC before start…

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 Phase II, multicentre, double-blind, randomised, placebo-controlled study
of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn*s disease recurrence
(STOP-Postoperative Endoscopic Recurrence Study)

Primary objective:To demonstrate the efficacy of Rifaximin -EIR 400 mg Tablet (800mg /BID, total daily dose 1600 mg) versus placebo in the prevention of endoscopic Crohn*s disease recurrence following ileocolonic resection

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…

Phase II study of preliminary diagnostic performance of [68Ga]-NeoBOMB1 in adult patients with malignancies known to overexpress Gastrin Releasing Peptide Receptor

Primary Objective• To characterize preliminary targeting properties of [68Ga]-NeoBOMB1 in patients with malignancies known to overexpress GRPR.Secondary objectives• To assess safety and tolerability of a single diagnostic dose of [68Ga]-NeoBOMB1…

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)…

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

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…

Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo)Radiotherapy versus Total mesorectal excision for early Rectal Cancer? - STAR-TREC study

This study has been transitioned to CTIS with ID 2024-516106-31-00 check the CTIS register for the current data. STAR-TREC is a phase II feasibility study that will evaluate whether it is possible to accelerate patient recruitment from 2 per month,…

Using Interactive Virtual Reality Exposure to Understand Aggressive Behavior Problems in Youth; A pilot-study

The current pilot-study aims to validate Virtual Reality (VR) environments that elicit variance in virtual aggression and social information processing (SIP) and consist of the following research questions.1. Do children experience VR environments…

Visualizing beta cells in patients with a history of gestational diabetes

This study has been transitioned to CTIS with ID 2024-520392-27-00 check the CTIS register for the current data. The primary objective is to evaluate the difference in 68Ga-exendin tracer accumulation in the pancreas of women with and without a…

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.

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…

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…