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 trial examines whether low grade suppression of the initial inflammatory process of sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work productivity, and whether this intervention prevents disease progression and reduces total health-care costs.
Rationale: Chronic abdominal pain is a frequently occurring condition. Although hardly ever considered, the abdominal wall is the primary cause in 10-30% of cases. Most often it is caused by entrapment of an intercostal nerve in the anterior rectus sheath, the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). Treatment consists of local anaesthetic injections combined with methyl-prednisolon. When ineffective, a neurectomy at the site of penetration out of the ventral rectus sheet should be considered. This neurectomy however is effective in 73% of cases, leaving some 25% of patients in pain. Whether these refractory ACNES patients suffer from underlying pathologic pain disorders is subject to investigation, by using quantitative sensory testing (QST). Objective: To investigate nociceptive processing and possible underlying pathological pain processing mechanisms in ACNES patients. Study design: An observational case-control study. Study population: Patients treated for ACNES (n = 50) compared to healthy controls from an existing database. Measurements: Quantitative sensory testing (QST) of nociception, performed after treatment of ACNES for both successfully treated and refractory patients in comparison to healthy controls. Visual Analogue Scores (VAS) measured before, during and after testing procedures. Pain Anxiety Symptom Scale (PASS) and Pain Catastrophizing Scale (PCS) questionnaires. Main study parameters: Pressure pain and electrical pain thresholds as investigated by QST. Secondary study parameters are VAS-scores and results of PASS and PCS questionnaires.
The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.
Rationale: Patients with indolent or smoldering systemic mastocytosis can have severe disabling symptoms. Almost all patients have fatigue, a compromised quality of life, hampering normal functioning. Because this form of mastocytosis is not considered life-threatening, mast cell eradication has never been applied and patients receive only symptomatic therapy with histamine blockers. Midostaurin, a c-KIT inhibitor has shown activity regarding symptom control and decrease of malignant mast cells in patients with aggressive systemic mastocytosis (ASM) or mast cell leukemia
The study is a two-arm randomised phase III trial. Patients will be randomised to receive capecitabine (arm A) or S-1 (arm B). Bevacizumab may be added according to the choice of the investigator. Patients will be followed 3-weekly at the outpatient clinic, toxicity will be assessed according to study protocol guidelines. Patients will be evaluated every 3 cycles for response. Upon disease progression patients will be treated according to the local investigators
Rationale: Approx. 80% of acute stroke patients suffer from acute hemiparesis. Stroke patients have not reached their full potential when they are discharged from hospital. It is proven that extra training opportunities lead to further improvement. To date, new training possibilities, such as robotic techniques for rehabilitation, virtual reality training systems and tele-rehabilitation are being developed to aid in the training of stroke patients. Objective: To obtain preliminary evidence on the efficacy of an individualised, intensive 6-week technology-assisted training regime, featuring a robotics-based self-adapting arm training system (I-TRAVLE) in a virtual context, focussed on improvement of arm function and arm skill performance in chronic stroke patients with low to moderate proximal (shoulder/arm) muscle strength. Study design: single arm prospective cohort study. Study population: 16 stroke patients in the chronic phase after their stroke, aged >=18, diagnosed with a central paresis of the arm, having low to moderate proximal (shoulder and arm) muscle strength. Intervention (if applicable): Haptic feedback of the I-TRAVLE robot either supports or challenges the patient to perform movements of the arm, thereby training motor control and co-ordination of the affected arm. Also strength and endurance of arm muscle use may be trained. The I-TRAVLE based training will last 6 weeks. Each week participants will attend training sessions on 3 days, during which they will train 2x 30 minutes, interspaced by at least half an hour to avoid (general) fatigue and overuse. Main study parameters/endpoints: Baseline measurements will be performed 3x prior to the start of the intervention, each interspaced by 1 week to assess baseline stability or any fluctuations in baseline values. In these chronic stroke patients spontaneous improvement is not expected. Also measurements will be performed at 0 weeks and at 12 weeks post training. Primary outcome measures: Wolf Motor Function Test, ABILHAND, and Goal Attainment Scaling. Secondary outcome measures are: motricity index, plate tapping task, active range of motion, perceived strength and fatigue.
This non-interventional, observational, open-label multi-center follow-up study of patients from the U-Act-Early trial (ML22497) will evaluate the long-term efficacy and safety of starting tight control treatment with RoActemra/Actemra (tocilizumab) and/or methotrexate in patients early in the disease followed by treatment according to standard of care in routine clinical practice in a three year follow-up, independently of what treatment the patient will be receiving.
The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition colonoscopy with that of standard high definition colonoscopy
Hypertrophic cardiomyopathy (HCM) is the most common monogenic heart disease and the most frequent cause of sudden cardiac death (SCD) in the young. It is characterized by unexplained left ventricular hypertrophy (LVH), diffuse and patchy fibrosis, and myofibrillar disarray. While the majority of patients remain asymptomatic, prognosis is poor in a subset who present with SCD or progress to heart failure (HF). Current methods to predict risk of these adverse events and to target therapy are limited. Current medical therapy does not protect against SCD, nor does it prevent development of HF. Therefore, the identification of novel risk markers would help develop therapeutic targets aimed at altering the phenotypic expression to impact the natural history, especially SCD and HF. Cardiovascular magnetic resonance (CMR) is emerging as a powerful tool for diagnosis and risk stratification in HCM including assessment of LV mass and pattern of hypertrophy. Late gadolinium enhancement by CMR is a marker of focal myocardial fibrosis which is thought to underlie the arrhythmogenic substrate as well as promote development of HF. The investigators hypothesize that HCM patients with a higher primary outcome event rate can be identified by novel CMR findings. The majority of cases of HCM are autosomal dominant and about 60% are caused by mutations in genes encoding cardiac sarcomeric proteins. However, the relationship between genetic mutation, disease phenotype, and clinical outcomes remains poorly understood. The investigators hypothesize that HCM patients with sarcomeric HCM mutations will have a higher primary outcome event rate and more marked myocardial pathology on CMR than those without. Furthermore, there may be a link between sarcomeric mutations and fibrosis, as mutation carriers with overt HCM as well as those without hypertrophy have elevated markers of collagen turnover. The investigators therefore hypothesize that serum biomarkers of collagen metabolism in HCM will predict outcomes. Thus, the Specific Aim is to develop a predictive model of cardiovascular outcomes in HCM by: 1) using exploratory data mining methods to identify demographic, clinical, and novel CMR, genetic and biomarker variables associated with the outcomes and 2) develop a score from the predictive model that can be used to assess risk given a patient's combination of risk factors, thus establishing the evidence base to enable clinical trial design to reduce morbidity and mortality in HCM in a cost-effective manner.
The main purpose of this prospective, multicenter, open-label phase II study, was to evaluate the efficacy and safety of pasireotide alone or in combination with cabergoline in patients with Cushing's disease.