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.
This is a multicenter, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of the addition of UMEC (62.5 microgram[mcg]) when administered once-daily via dry powder inhaler (DPI) to Inhaled corticosteroid/ Long-acting beta2-agonist (ICS/LABA) twice-daily compared with placebo via DPI added to the ICS/LABA therapy over a treatment period of 12 weeks in subjects with COPD. This study is designed to investigate the addition of UMEC to ICS/LABA combinations at approved doses and frequencies for the treatment of COPD including SERETIDE™ 500/50 mcg twice daily, Fluticasone Propionate/Salmeterol Combination (FSC) 500/50 twice daily generic products such as AIRFLUSAL FORSPIRO inhaler 500/50 mcg twice daily or ROLENIUM ELPENHALER inhaler 500/50 mcg twice daily and SYMBICORT TURBUHALER inhaler at doses of 200/6 mcg twice daily and 400/12 mcg twice daily, over 12 weeks in subjects with COPD. Albuterol/salbutamol metered-dose-inhaler (MDI) or nebules will be issued throughout the study for use as-needed (prn). Subjects who meet the eligibility criteria will be randomly assigned to one of the following blinded study treatment regimens in equal proportion (1:1): UMEC 62.5 mcg once-daily and Placebo once-daily. Approximately 230 subjects (115 subjects per treatment) will be randomized in order to complete at least 206 evaluable subjects. The total duration of the study will be approximately 14 weeks for each subject. UMEC is a Long-acting Muscarinic Antagonist (LAMA) currently under development as a monotherapy, as a combination product with a LABA, vilanterol (VI), for the treatment of COPD, and as a combination product with an ICS, fluticasone furoate (FF), for the treatment of asthma. The UMEC/VI combination 62.5/25 .mcg once-daily has been approved in the United States (U.S.) and Canada for COPD under the trade name ANORO™ ELLIPTA™ and is under regulatory review in other countries. SERETIDE, ANORO, and ELLIPTA are trade marks of the GlaxoSmithKline Group of Companies. Other company or product names mentioned herein may be the property of their respective owners.
The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.
The purpose of this study is to determine whether lamotrigine can improve cognitive and neurophysiological deficits in adolescents with Neurofibromatosis type 1.
The PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent clinical track record, good survival rates (98% 10 years survival in patients aged < 55 years)(Keenan et al., 2012) and minimal early migration as measured with RSA (0.5mm MTPM at two years follow-up)(von et al., 2009). The ATTUNE™ Knee by DePuy Synthes is an advancement in knee replacement options. It is designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. To date (March 2013), more than 3,500 patients have received an ATTUNE Knee as part of a limited launch and positive feedback was received regarding patient recovery, stability and motion. The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes of two TKR prostheses: the Cemented ATTUNE™ Fixed Bearing Cruciate Retaining Knee System and the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System, both by DePuy Synthes, Warsaw, Indiana, USA. The primary objective of this study is to compare the magnitude and pattern of migration of the prostheses (Femoral and Tibial component). The secondary objective of this study is to compare clinical and radiological outcome of the prostheses and PROMS. The tertiary objective of this study is to compare clinical and radiological outcome and PROMS of the prostheses with migration data. This study is designed as a single-blind, randomized trial between the ATTUNE™ Knee System and PFC Sigma Knee System. 32 patients with the ATTUNE™ Knee System and 32 patients with PFC Sigma Knee System will be included in this study. The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Medisch Centrum Haaglanden, The Hague, The Netherlands. Annually 300 TKA procedures are performed in this department, of which about 90% is Osteo Arthritis (OA) and 10% Rheumatoid Arthritis (RA) and other indications. We anticipate that inclusion can be accomplished within a 1 year period and that the total study duration is 3 years. Main study parameters/endpoints are: - Migration of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA). - Patient Reported Outcome Measures by means of questionnaires.
The aim of this registry is to assess the recurrence of prostate cancer at 1 and 5 years, as well as the change in functional outcomes (e.g. incontinence or erectile function) from baseline. Secondary objectives are to establish which indications lead to treatment with IRE Nanoknife® setting and safety assessment measured by number of complications and adverse events.
Primary Objective: To evaluate long-term safety of alemtuzumab. Secondary Objectives: - To evaluate long term efficacy of alemtuzumab. - To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment. - To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab. - To evaluate as needed re-treatment with alemtuzumab and other DMTs.
The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory tract complication, being free of any supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.
The current standard treatment of resectable esophageal cancer consists of neoadjuvant chemoradiation followed by resection. However, some patients develop recurrent disease despite chemoradiation and additional (systemic) treatment might have been indicated. Other patients show a (nearly) complete response after chemoradiation and could possibly have been treated with a less extensive treatment regimen. In patients without a threatened circumferential resection margin (CRM) and lymph node metastases chemoradiotherapy could possibly be omitted. Better stratification of patients with esophageal cancer is therefore urgently needed. Functional magnetic resonance imaging techniques (MRI) can provide in vivo, quantitative information on tumor biology and may prove to be a useful non-invasive tool for this purpose. In this project, ultra-small superparamagnetic particles of iron oxide (USPIO) enhanced MRI using ferumoxytol (Rienso®), diffusion weighted MRI (DWI) and T2* MRI will be developed, both in terms of improvement of acquisition and data processing techniques.
In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and prior to sleep
Purpose of this study is to treat glucocorticoid induced hyperglycemia due to glucocorticoid pulse therapy in a efficacious, safe and convenient way. Patients with acute exacerbation of COPD treated with glucocorticoid pulse therapy and at high risk for glucocorticoid induced hyperglycemia (defined as known type 2 DM or glucose > 10mmol/l at admission) will be randomized to treatment of dapagliflozin or placebo orally, once daily. Percentage of time within glucose target range (3,9-10 mmol/l) and incidence rate of hypoglycemia will be compared between dapagliflozin group and placebo group.