There are about 13332 clinical studies being (or have been) conducted in Netherlands. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Our primary objective is to set up the Human Rhinovirus (HRV)-model in our centre. In addition, to facilitate future clinical trials, we want to determine optimal read-out parameters and read-out time points for experimental HRV infection in healthy volunteers. Furthermore, we want to analyze to what extent HRV can cause systemic immune effects, and we want to test if subjects with antibodies against HRV can be re-infected with the same virus, and if the presence of HRV antibodies influences the local clinical and immunological response upon infection. Additionally, to gain insight in the immune modulating properties of HRV, we want to investigate the immunological response to a HRV re-infection within one week to determine if there are mechanisms that provide immediate protection against re-infection. This facilitates a cross-over design of future pharmacological intervention-trials. Furthermore, we want to investigate the capacity of HRV infection to modulate the systemic immune response by analyzing the response of leukocytes ex vivo stimulated with different stimuli. Moreover, we want to evaluate the effects of HRV-16 infection on the host transcriptome and metabolome. Finally, The influence of HRV-16 infection on nasal and gut microbiota will be assessed.
This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with Chronic Obstructive Pulmonary Disease (COPD). Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 500/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.
This is study in healthy human volunteers to determine the absorption, metabolism, and excretion (AME) profile of ARN-509 as well as its absolute oral bioavailability (BA).
The purpose of this study is to investigate the safety and tolerability of LY3045697 after multiple doses and to determine how long LY3045697 remains in the body. Each participant is expected to complete 3 dosing periods. At least 7 days will pass between dosing periods.
This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study. The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.
Cerebral Amyloid Angiopathy (CAA) is a condition caused by the build-up of a protein called amyloid, predominantly Aβ40, within the walls of brain blood vessels, especially those blood vessels in the occipital lobe of the brain. Probable CAA may be defined as two or more hemorrhages in the brain cortex in individuals 55 years of age or older. This study will examine the study drug (PF-04360365) vs. placebo (saline) at 10 mg/kg - Day 1 and the maintenance dose of the study drug (PF-04360365) vs. placebo (saline) at 7.5mg/kg on Days 30 and 60. Subjects will be followed for 6 months after receiving the last dose of study medication.
The objective of this cross-sectional study is to obtain insight in the characteristics (nutritional status and level of physical activity) of sarcopenic compared to non-sarcopenic community-dwelling older people. There is one measurement moment and measurements will take place at the participant's home.
Patients with a hematological malignancy who are undergoing intensive chemotherapy need a central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they are not used. The purpose of this study is to determine whether concentrated citrate locking, compared to heparin, reduces the incidence of central venous catheter-related thrombosis and infections in patients with hematological malignancies undergoing intensive chemotherapy.
The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.
Objectives The investigators present an online application to empower and inform patients and improve guideline adherence in unexplained subfertility. Thereby the investigators expect to reduce overtreatment in fertility care with higher quality of care. Methods The investigators conduct a prospective cohort study including couples with a diagnosis of unexplained subfertility. Couples consulting their general practitioner with an unfulfilled child wish will be offered to use FertiScreen. FertiScreen is an online application, in which patients are asked questions about their fertility problem (ie menstrual cycle, age, duration of child wish and the results of the Chlamydia Trachomatis antibody titre and semen analysis). FertiScreen then uses the validated prediction model of Hunault to calculate couples' chance of natural conception during the next twelve months. In addition, patients can find links to extra information concerning subfertility. Couples can then initiate an online consultation with their general practitioner and a gynaecologist, in order to discuss their results and prognosis. When the calculated prognosis of spontaneous conception within one year is >30%, tailored expectant management for 6-12 months will be advised, as no benefit can be expected from fertility treatment. Questionnaires will be sent to patients as well as to their caregivers (general practitioner, gynaecologist). These questionnaires will focus on the use of FertiScreen (System Usability Scale) and the different domains of quality of care (effectiveness, cost-effectiveness, safety, patient-centredness). For the latter, the investigators use the Hospital Anxiety and Depression Scale and the Patient Centredness Questionnaire for Infertility. In order to be able to draw conclusions, the investigators will conduct a baseline measurement among couples with unexplained subfertility who have been referred to a fertility clinic. Their data will be abstracted from their medical records and they will receive the aforementioned questionnaires as well (except for the System Usability Scale). The investigators will recruit couples presenting to general practitioners in the Nijmegen area (which for second line treatment consists of one general hospital and one academic hospital). To detect an increase in guideline adherence of the current 60% to 75% with a power of 80% (P<0,05), the investigators need to include 152 couples in the before as well as in the after measurement.