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.
Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a very high success rate. It works by heating and thereby obliterating the vein. Steam ablation is a new therapy that also works by heating and thereby obliterating the vein. The hypothesis of this study is that steam ablation is as effective as laser ablation, but that it results in better secondary outcomes (e.g., lower pain scores).
The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.
The main objective of this study is to explore whether multiple trials with individual patients (N-of-1 trials) can produce a reliable evidence base for coverage decisions on clinical and cost-effectiveness of drug treatment for patients with rare diseases. As a case study, we will study the clinical and cost-effectiveness of Mexiletine in patients with Non-Dystrophic myotonia. The results of this analysis will be compared with the results obtained from a recently published international, multi-centre, randomized, placebo-controlled trial of Mexiletine in patients with Non-Dystrophic Myotonia (clinicaltrials.gov Identifier: NCT00832000). The secondary objective of this proposal is to assess whether mexiletine improves myotonia measured (both quantitatively and qualitative) in patients with non-dystrophic myotonia.
SUMMARY Rationale: Fifty-six percent of patients with Obstructive Sleep Apnea (OSA) are position dependent, defined as having an AHI, which is at least twice as high in supine sleeping position compared to the AHI during sleep in other positions. Standard therapy for patients having mild or moderate POSA is treatment with an Oral Appliance Trainer (OAT). Recently a new device Sleep Position Trainer (SPT) is been introduced especially for patients with POSA. Objective: To compare the effect of positional therapy with the SPT versus OAT on polysomnographic (PSG) parameters, to evaluate the compliance and measuring the possible learning effect that might occur with POSA patients using the SPT for positional therapy over a long term. Study design: Randomised controlled trial Study population: The participants of the research will be recruited from the departments of Otolaryngology and Clinical Neurophysiology, Saint Lucas Andreas Hospital, Amsterdam, the Netherlands. Participants will be males or females older than 18 years with diagnosis of positional OSA. Intervention: The SPT is a sensor positioned in an elastic band attached around the body. The SPT measures the body position and vibrates when the patient lies in supine position. Oral appliance therapy (OAT) is an intra-oral prosthesis, which holds the mandible in a protrusive position. Because of this position more pharyngeal space will be available and the AHI will decrease. After randomisation the first group (n=45) will sleep for a period of 90 +/- 2 days with the SPT every night. The second group (n=45) will also sleep for a period of 90 +/- 2 days only with OAT. After this period the PSG is repeated. Long- term outcome in AHI is measured by repeating the PSG after 1 year. Main study parameters/ endpoints: Primary endpoints; reduction of PSG parameters, in particular AHI, AI, HI, DI, reduction of % of sleeping supine sleep position, without disturbance of the sleep quality. Secondary endpoints: Outcome of Quality of Life questionnaires; EQ-5D, ESS, FOSQ and MFIQ. Compliance and learning effect will also be evaluated for the time period of 3 and 12 months. Finally cardiovascular parameters like blood pressure, pulse rate and BMI/neck circumference will be assessed. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks for patients participating in this study are negligible. Inconveniences of the SPT can be discomfort caused by irritation of the band, difficulties with an increased sleeping period on the side or difficulties sleeping with the SPT. This can be compensated by the expected improvement of sleep quality caused by the therapy. Possible side effects of OAT may be discomfort in the jaw, sensitivity of the teeth and a dry mouth. Withdrawing from this therapy means immediate relief of inconveniences.
The primary purpose of the study is to determine the safety and efficacy and to generate PK and biomarker data for the combination of Pomalidomide and low-dose Dexamethasone in patients with relapsed or refractory multiple myeloma, with moderate or severe renal impairment.
This is an interventional, randomized controlled study in health volunteers that involves collecting data on raw EEG waves measuring various combinations of anesthetic drugs during standardized drug titration.
To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 1000 patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with other approved treatments for metastatic disease and for whom a decision has been made by the physician to treat with regorafenib according to local health authority approved label. It is the aim of this observational cohort study to further characterize safety and effectiveness of regorafenib in routine clinical practice setting. Healthcare resource utilization in the routine provision of care is becoming increasingly important from a health economics and outcomes research perspective. Therefore, another aim of this observational cohort study is to capture healthcare resource associated with the management of treatment emergent adverse events in the real world setting. The primary objective of this study is to further characterize safety of regorafenib use in routine clinical practice settings. The secondary objective of this study is to assess the effectiveness of regorafenib in routine clinical practice settings as measured by Overall Survival (OS), Progression Free Survival (PFS) and Disease control rate (DCR). Health Related Quality of Life (HRQoL) Data will be collected in applicable countries.
The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy