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Influenza vaccination in patients with Myasthenia Gravis

The main objective of this study is to investigate the effectiveness of the humeral immune response after influenza revaccination in patients with MG with acetylcholine antibodies (AChR MG). The secondary objectives are to determine if vaccination…

Trigeminovascular effects of propranolol in migraine treatment

To determine the mechanism of action of propranolol in the prophylactic treatment of migraine.

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.

Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event
International, multi-centre, randomized, double-blind placebo-controlled phase II study.

Efficacy and safety trial with S 44819 after recent ischemic cerebral Event

Visual Disorders in Parkinson's Disease

The primary aim of this study is to validate a screening instrument for ophthalmologic disorders using full, in depth ophthalmologic assessment as the gold standard. Secondary aims include:* To study the severity and clinical impact of different…

Pharmacokinetic analysis of sinecathechins ointment 10% (Veregen) by means of Raman micro-spectroscopy in the skin of healthy volunteers

To gain insight in the pharmacokinetics of sinecathechins ointment 10% (Veregen) applied on healthy skin, using Raman micro-spectroscopy and chromatography of tape strips.

Feasibility of exoskeleton training for home use for patient with motor complete spinal cord injury.

In the present study, the feasibility of a training program with an exoskeleton for home use for people with motor complete SCI (ASIA A and B) will be examined. Participant will also be evaluated based on individual goal setting, patient…

A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION

Objectives: For patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) enrolled in this study, the objectives are as follows:Primary: -To assess the efficacy of bardoxolone methyl relative to placebo.Secondary…

The influence of breathing techniques and exposure to cold on inflammation during human endotoxemia, an explorative study

The primary objective of the present study is to determine the effects of the `strength ventilation` breathing technique and exposure to cold, both separately and in combination, on the inflammatory response during human endotoxemia. To this end, we…

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…

Parenting and the brain

To gain insight in the neural basis of stereotypes in mothers (i.e., gender, prematurity).

A Phase 1/2 Multicenter Study of BMS-986012 in Subjects with Relapsed / Refractory Small Cell Lung Cancer (CA001-030)

Primary ObjectiveThe primary objectives are to determine the multidose safety, tolerability, dose limiting toxicities (DLTs), and the maximally tolerated dose (MTD) of BMS-986012 administered as monotherapy in subjects with relapsed/refractory SCLC.…

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…

A randomized and open-label dose-finding, phase 2, efficacy, safety and pharmacokinetic study of once-per-cycle prophylactic injections of ANF-RHO TM versus pegfilgrastim (NeulastaR) in non-metastatic breast cancer patients at high risk of chemotherapy-induced neutropenia (CIN)

Primary Objective:- To assess the efficacy of escalating doses of ANF-RHO versus Neulasta in the duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] * 2.0 x 109/L) in the first chemotherapy cycle (21-day cycle FE100C).Secondary…

A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination with Ipilimumab versus Nivolumab in combination with Ipilimumab placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The aim of the study is to compare the Overall Response Rate (ORR) and assess Duration of Response (DoR) of the treatment of nivolumab in combination with ipilumumab vs. nivolumab in combination with ipilimumab placebo, as determined by a blinded…

A PHASE 1/2 MULTICENTER, OPEN-LABEL STUDY TO DETERMINE THE RECOMMENDED DOSE AND REGIMEN OF DURVALUMAB (MEDI4736) IN COMBINATION WITH LENALIDOMIDE (LEN) WITH AND WITHOUT DEXAMETHASONE (DEX) IN SUBJECTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA (NDMM)

Main objective:Determine the recommended dose of durvalumab in combination withLEN +/- dex in subjects with NDMM.Secondary objectives:- Evaluate the safety and preliminary efficacy of durvalumab incombination with LEN +/- dex in subjects with NDMM-…

A Phase III, Randomized, Open Label Trial of Nivolumab in combination with Ipilimumab versus Pemetrexed with Cisplatin or Carboplatin as First Line Therapy in unresectable Pleural Mesothelioma

Primary Objectives:• To compare progression free survival (PFS) as determined by blinded independent central review (BICR) and overall survival (OS) of nivolumab combined with ipilimumab to pemetrexed plus cisplatin or carboplatin regimen as first…

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the
Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Regimens in Adult Subjects Hospitalized with Respiratory Syncytial Virus

Primary ObjectiveFor Part 1:The primary objective is to characterize the pharmacokinetics (PK) and to confirm the population PK (popPK) model derived from healthy volunteers in hospitalized adults who are infected with RSV.For Part 2:The primary…

A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination with Nivolumab
and/or Ipilimumab in Subjects with Advanced Solid Tumors

The primary objective is to determine the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of BMS-986178 administered alone or in combination with nivolumab and/or ipilimumab in…

A Phase 1/2, Single-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of Subcutaneously Administered
ALN-GO1 in Healthy Adult Subjects, and Patients with Patients with Primary Hyperoxaluria Type 1

Primary* Evaluate the safety and tolerability of single- and multiple-ascending doses of ALN-GO1, respectively, in healthy adult subjects and in patients with PH1Secondary* Characterize the pharmacokinetics (PK) of ALN-GO1* Evaluate the…