Search for a trial

Phase 1-2 study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer.

Primary: Phase I part 1) Assessment of the recommended dosing and schedule for metronomic cyclophosphamide when administered in combination with fixed dose (10 mg) oral everolimus in patients with mRCC with respect to the selective induction of CD4+…

A phase Ib, open-label, multi-center, dose escalation and expansion study of an orally administered combination of BKM120 plus MEK162 in adult patients with selected advanced solid tumors

Primary:To determine the MTD and/or RP2D of BKM120 and MEK162 in combination when administered orally to adult patients with selected advanced solid tumors. Secondary:• To characterize the safety and tolerability of the oral combination of BKM120…

PreCARA: Preconception Counselling in Active Rheumatoid Artritis and other chronic inflammatory arthritides;
Preconception counselling for women with rheumatoid arthritis (RA) or another chronic inflammatory arthritis and a pregnancy wish, which is evaluated in a prospective observational study monitoring pregnancy, delivery, postpartum period of the mother, and (growth) parameters of the child.

In the present study we will evaluate the standardized care protocol developed in our outpatient clinic, intended to guide counselling for medication use prior to pregnancy. This protocol guides treatment decisions based on disease activity,…

A Multi-national Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC 0129-0000-1003 (N8-GP) when Administered for Treatment and Prophylaxis of Bleeding in Patients with Haemophilia A

Co-Primary Objectives* To evaluate the immunogenicity of N8-GP in previously treated patients with haemophilia A* To evaluate the clinical efficacy of N8-GP in bleeding prohylaxis (number of bleeds during prophylaxis)Secondary Objectives* To…

Pressure-Flow Measurements Directly after Primary PCI to Predict Late Occurrence of Microvascular Obstruction

In the present study we aim to determine the value of microvascular resistance measurements in the acute setting to predict the occurrence of MVO in the following days, using the combined pressure-flow wire. Therefore patients with an acute MI will…

Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…

Phenotyping and genotyping of retinal dystrophies in the Netherlands.

The goal of this study is to collect and clinically characterize a large cohort of patients with hereditary retinal dystrophies in the Netherlands. The study cohort will be used to identify the genetic causes underlying these diseases, and to…

Risk factors for colorectal cancer in patients with inflammatory bowel disease undergoing surveillance: a prospective cohort study

1. To confirm established and identify new risk factors for colorectal cancer in a prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or colorectal cancer will be the primary outcome.2. To provide evidence that mucosal…

Development of fMRI tasks and scan protocols

Development of (f)MRI tasks and scan protocols and to define the optimal parameters in preparation of a (f)MRI study

Expedite and facilitate diagnostic work up of transient ischemic attack and minor ischemic stroke: dynamic 320-detector row CT angiography of cardiac and carotid sources of emboli compared to currrently used diagnostic procedures

Main study objective of this study is:To evaluate whether the 320-detector volumetric CT technology can replace carotid duplex scanning and TEE in the diagnostic workup in TIA/IS patients. Specific aims of this main study objective are:1. To assess…

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM
SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN*S DISEASE (OPERA II)

The primary objective of this study is to monitor the safety and tolerability of PF 00547659 during long term treatment. Secondary objectives: * The secondary objective is to assess pharmacokinetics and immunogenicity of PF 00547659.* Exploratory…

Microbiological etiology of community acquired pneumonia in immunocompromised adults.

Objective of the study is to quantify the microbiological etiology in immunocompromised patients, at least 18 years of age, with CAP needing hospitalization. And to determine the severity, antibiotic use and outcome of CAP in immunocompromised…

Measuring work-of-breathing in mechanically ventilated children

The primary objective for this study is to compare the level and time course of the patient work-of-breathing during PS ventilation with the work-of-breathing during SIMV-PS ventilation with a lower rate of breaths per minute delivered by the…

Efficacy and Safety of NNC 0129-0000-1003 during Surgical Procedures in Patients with Haemophilia A

Primary Objective: * To evaluate the haemostatic effect of N8-GP during surgical procedures in patients with haemophilia A. Secondary Objectives * To evaluate the general safety including immunogenicity of N8-GP when used for prevention and…

Serial Biomarker meaSurements and new echocardiographic techniques in chronic Heart Failure patients result in Tailored prediction of prognosis

Primary Objectives: - To investigate whether disease progression in individual patients with CHF can be accurately assessed by serial measurements of disease-related (novel) biomarkers.- To investigate whether dynamic biomarker patterns as…

D-dimer and Factor XIII activation peptide in cerebral venous thrombosis (CVT)

To assess the sensitivity and negative predictive values of D-dimer- and FXIII activation peptide (AP-FXIII) values in order to exclude to exclude CVT in patients with clinical suspicion of CVT.

An Open-Label Extension of Study HGT-SAN-055 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Administration of rhHNS in Patients with Sanfilippo Syndrome Type A (MPS IIIA)

The primary objectives of this study are: • To determine the longterm safety and tolerability of rhHNS administered via an intrathecal (IT) route once monthly for 8 years in patients with MPS IIIA, who have received and tolerated 6 months of…

An open-label, single-arm, phase II, multicenter study to evaluate;the efficacy of vemurafenib in metastatic melanoma patients with brain metastases

The primary objective of this trial is to evaluate the efficacy of vemurafenib using BestOverall Response Rate (BORR), as assessed by an Independent Review Committee (IRC)using RECIST, v1.1 criteria in the brain of metastatic melanoma patients with…

BRCA mutations and ovarian ageing in normo-ovulatory women

Primary objective: To confirm that a BRCA-mutation is a determinant of advanced ovarian ageing by using serum-AMH as ovarian reserve test.Secondary objective: To confirm that a BRCA-mutation is a determinant of reduced reproductive health/outcome.

Q-Kids

To estimate the risk of Q fever infection in children and adolescents in various exposure groups, estimate the true regional incidence of Q fever infections in children and adolescents, identify associated risk factors, and assess the impact of Q…