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Safety and protective efficacy of BCG vaccination against controlled human malaria infection

The primary objective is to determine the safety and tolerability BCG vaccination followed by controlled human malaria infection; and to determine the protective efficacy BCG vaccination against a controlled human malaria infection.

Human intestinal ischemia and reperfusion

This study aims at (further) revealing the pathophysiology of intestinal IR in man, with a specific interest for the role of proteases and protease-activated receptor-2 (PAR-2), cellular and inflammatory changes, barrier function and intestinal…

A Phase 2, Single dose, Open-Label, Exploratory Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

4.1 Primary• To estimate the Sensitivity and False Positive rate of OTL38 for malignancy detection during Near Infrared Imaging (NIR).• To assess the safety and tolerability of single intravenous doses of OTL384.2 Secondary• To assess the safety of…

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…

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).

Randomized Phase II, 2-arm study of Pembrolizumab after high dose radiation (SBRT) versus Pembrolizumab alone in patients with advanced non-small cell lung cancer.

Primary objective:To observe an increase in Overall Response Rate (ORR) from 20% in the pembrolizumab alone arm to 50% in the pembrolizumab after SBRT arm at 12 weeks. Secondary Objective: - Disease Control Rate, defined as the percentage of…

Phase II study with oral fibroblast growth factor-1 inhibitor BIBF1120 as treatment in lung carcinoma patients harboring fibroblast growth factor receptor-1 gene amplification (NVALT-15 study)

Primary: To assess PFS of lung cancer patients with an FGFR1 gene amplified in their tumor cells upon treatment with BIBF1120.Secondary: To assess response rate, duration of response, overall survival and safety.

A phase II study of Vorinostat in patients with Polycythaemia Vera and Essential Thrombocythaemia

1. To evaluate efficacy of vorinostat in the treatment of patients with polycythaemia vera (PV) and essential thrombocythaemia (ET) 2. To evaluate if vorinostat as monotherapy of patients with PV and ET is followed by a decline in clonal…

Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Safety objective:• To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects withinoperable CTEPH.Efficacy objectives:• To evaluate the long term effects of macitentan 10 mg on exercise capacity andfunctional class (FC).

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…

A Phase 2b, double-blind, randomized, placebo-controlled study of RVT-101 in subjects with dementia with Lewy bodies (DLB).

Primary• To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician*s Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment• To assess the effects of RVT-101 versus…

Improving cognitive functioning in Parkinson*s disease with transcranial Direct Current Stimulation (PD-tDCS)

Determine the efficacy of atDCS as compared to ctDCS and sham stimulation in the improvement of executive functioning in PD-MCI.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation

2.1 Primary Objectives• Evaluate the safety and tolerability of 2 fixed doses of FRM-0334 (300 and 500 mg daily in 2 sequential periods) over 28 days in subjects with prodromal to moderate FTD-GRN• Assess the PD effects of FRM-0334 on the change…

Stereotactic body radiotherapy for cT1c - cT3a prostate cancer with a low risk of nodal metastases (<= 20%, Roach index): a Novalis Circle Phase II prospective randomized Trial*

Aim of this study is to investigate the tolerance and the outcome of extreme hypofractionated RT for prostate cancer by delivering a high dose using two alternative time schedules, a short and long treatment interval.

A double blind, randomized, placebo controlled, cross-over study to validate the predictive power of the demarcation formula for Lybrido and Lybridos efficacy in women with female sexual interest/arousal disorder, in the domestic situation.

Primary Objective• To validate the existing demarcation formula (consisting of psychometric and biological markers) which predicts the sensitivity to Lybrido or Lybridos in women with female sexual interest/arousal disorder (FSIAD with or without…

A phase II study of sorafenib and metformin in patients with locally advanced and/or metastatic non-smal cell lung cancer (NSCLC) with a K-Ras mutation

To assess the efficacy of combined treatment with sorafenib and metformin.

Effect of high frequency transcranial magnetic stimulation on negative symptoms and cognitive functioning in schizophrenia: a combined treatment and neuroimaging study

Transcranial magnetic stimulation (TMS) is a non-invasive, save method to stimulate the cerebral cortex and thereby alter neuronal function. In TMS a coil, which delivers brief magnetic pulses is placed adjacent to the scalp. The magnetic field…

A 4-part Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 in healthy volunteers and in patients with immune thrombocytopenic purpura.

The purpose of this study is to investigate how safe the new compound M254 is and how well it is tolerated when it is administered to healthy volunteers and patients with immune thrombocytopenia (ITP). M254 has not been administered to humans before…

Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication

Primary objective* To evaluate the efficacy in terms of overall survival (OS) of erlotinib, everolimus and dasatinib in combination with radiation therapy, in patients with a DIPG both: - compared to the other experimental treatments by comparisons…

A Phase 2 Proof-of-Concept Study to Separately Evaluate the Activity of Talacotuzumab;(JNJ-56022473) or Daratumumab in Transfusion-Dependent Subjects with Low or;Intermediate-1 Risk Myelodysplastic Syndromes (MDS) who are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

The purpose of this study is to separately evaluate 2 agents with different mechanisms of action that may be effective in subjects with low-risker MDS. The design of this study will allow an unbiased assessment of which agent, if either, will…