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.
A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.
Rationale: For resectable esophageal cancer the standard therapy is 5 weeks of neoadjuvant chemoradiotherapy (nCRT) followed by surgery 6-8 weeks afterwards. Surgery is performed independent of the response to nCRT and is associated with substantial morbidity. A pathological complete response (pCR) after nCRT is seen in 28-34% of patients. Pathological non-responders (pNR) most probably do not benefit from nCRT but are exposed to its toxicity and delay from surgical therapy inevitably occurs in this group. Early identification of non-responders during nCRT would allow individualized decision making in continuation or discontinuation of nCRT. Furthermore, a tool is desirable to accurately assess the treatment response after nCRT to identify patients with a complete response. Studies in rectal cancer reported that tumor resection could be omitted in patients with persisting clinical complete response after 12 months. Also, in some esophageal cancer studies, complete responders in surgical and non-surgical treatment groups had comparable overall survival. These findings indicate the possibility to perform nCRT as sole treatment in patients with a complete response. Conversely, if residual tumor is demonstrated, this will support the decision to move to surgery. Objective: Diagnostic study to assess the distinct and combined value of anatomical and functional magnetic resonance imaging (MRI) and combined 18F-fluorodeoxyglucose positron emission tomography and computed tomography (PET-CT) in the evaluation of treatment response to nCRT for patients with esophageal cancer. Study design: Multi-center diagnostic study investigating the value of MRI and PET-CT in the imaging before, during and after nCRT for assessment of response to nCRT for resectable esophageal cancer. Imaging response measurements will be compared with the histopathological tumor regression grade (TRG) of the resection specimen as gold standard. Study population: 50 patients (>18 years) presenting at the UMC Utrecht or M.D. Anderson Cancer Center with resectable esophageal cancer, as determined by endoscopy and biopsy, computed tomography (CT) and endoscopic ultrasonography (EUS), receiving nCRT prior to surgery. Procedure: In addition to the conventional diagnostic work-up for esophageal cancer including a standard PET-CT before nCRT, two PET-CT scans will be performed during and after nCRT as well as three MRI scans before, during and after nCRT at the same time points. The first MRI (and standard-of-care PET-CT) scan session will be within the 6 weeks prior to the start of nCRT. The second scan session will take place after 10-14 days after the start of nCRT. The third and final scan session will be planned 1-2 weeks before surgery. Main study parameters/endpoints: Determination of the distinct and combined diagnostic value of anatomical and functional MRI and PET-CT in the evaluation of treatment response to nCRT for patients with esophageal cancer. Important imaging parameters include apparent diffusion coefficient (ADC) values, standardized uptake values (SUV) and volume measurements for the different time points. The differences of these values between time points are of particular interest (delta-ADC, delta-SUV, delta-volume). The sensitivity (%), specificity (%), negative predictive value (%), positive predictive value (%), and accuracy (%) of the different imaging parameters for correctly identifying histopathological complete response will be calculated.
Rationale: Skin cancer is common in Caucasians and often exists on sun-exposed areas, such as the face. Treatment of choice is mostly excision and result in an irreversible scar. As the incidence of skin cancer is rising, also among young people, it is important to obtain a good cosmetic outcome after treatment. It is believed that the type of closure of the wound after excision can influence the cosmetic result. Currently, primary closure of the excision can occur by transcutaneous (TC) or intracutaneous (IC) suturing. Both techniques are widely used among dermatologists and plastic surgeons and the choice is mainly dependent on the preference of the physician. Research comparing the cosmetic result of both techniques in the craniofacial area is lacking. Objective: Evaluation of the cosmetic result of transcutaneous sutures versus intracutaneous sutures in the craniofacial area. Study design: A randomized controlled single-blinded multi-center trial. Study population: Patients older than 18 years, with craniofacial skin tumor receiving surgery followed by primary closure at the department of Dermatology and Plastic Surgery of the Maastricht University Medical Centre, the department of Dermatology of Catharina hospital Eindhoven and the department of Plastic surgery of Orbis Medical Centre Sittard. Intervention: Excision of the tumor followed by IC sutures or TC sutures Main study endpoints: Cosmetic result measured on the Patient and Observer Scar Assessment Scale (POSAS) by the patient and the researcher 12 months after surgery. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients who participate have an indication for excision and will be assigned to one of the suture techniques. Both techniques are widely used in the regular patient care. Therefore, no extra risks are associated with it. Patients will be asked to visit the hospital 3 months and 1 year following treatment, at which point a questionnaire will be filled in and the redness of the scar will be measured by means of non-invasive techniques. In addition, patients will be asked to apply a sunscreen on the scar daily during the first three months of follow-up.
Phase Ib / II study to determine the Maximum Tolerated Dose and Recommended Phase II Dose, and to evaluate the safety and antitumour activity, of BI 836845 and everolimus in combination with exemestane in women with HR+/HER2- advanced breast cancer
Multinational, multicentre, non-pharmacological intervention, cross-sectional and longitudinal study.
Vitamin D has an immunomodulatory role. the aim of the present study is to assess the effect of vitamin D supplementation on exacerbation rate of COPD patient with a vitamin D deficiency.
The sentinel lymph node (SLN) procedure is a standard staging technique in several types of cancer. One of the major problems of SLN mapping in colorectal cancer is the lack of an optimal dye and technique for identification of the nodes. In this study the investigators used the Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly developed NIR laparoscope. The investigators compared two different injection techniques; subserosal and submucosal injection. Patients planned for a laparoscopic resection of a colorectal carcinoma without distant metastases were included. Dye was injected in the subserosa or submucosa of the bowel. Ten minutes after injection the investigators searched for fluorescent nodes with the NIR laparoscope. Fluorescent nodes were harvested and analyzed by the pathologist using H&E and additional immunohistochemistry.
Despite neoadjuvant chemoradiation regimens esophageal cancer remains a disease with poor outcome. The clinical benefit of HER2 targeting with trastuzumab has been shown in the setting of advanced disease and disease and safety of combining trastuzumab with chemoradiation in the curative setting has been established. In breast cancer, the added value of pertuzumab to standard treatment with trastuzumab has been shown both in the neoadjuvant and the metastastic setting. Taken together, there is a sound rationale to explore the combination of radiotherapy plus chemotherapy with trastuzumab and pertuzumab in HER2+resectable esophageal cancer. However, since the number of HER2+ patients in this setting is limited, and no data are available on the safety of this combination prior to major surgery, we propose to first conduct a feasibility study with this treatment stratgy. When the results of this study show that this treatment strategy is feasible, we will subsequently design a prospective study with efficacy as primary endpoint.
Dysfunctioning executive functioning, including working memory (WM), is related to rumination. Findings show that working memory capacity (WMC) can be increased by training. The current study explored by means of a double-blind randomized controlled trial whether an adaptive WM training could reduce rumination, anxiety and depression in a sample of 98 depressed and anxious individuals.
Background: Substance abusers show impaired working memory (WM) functioning. Promising findings show training WM results in an improved working memory capacity (WMC) and a decrease of clinical symptoms in a range of disorders, including alcohol addiction. Aim: To test the effect of a WM training in addition to treatment as usual (TAU) on substance use, craving, WMC, impulsivity, attention bias and psychopathology. Design: A randomized double-blind placebo-controlled trial with a parallel group design. The WM training adapted to participants' WMC whereas the placebo training consisted of non-adaptive easy versions of these tasks. Setting: Two departments of an addiction treatment clinic in Rotterdam, the Netherlands. Participants: 120 inpatients diagnosed with an alcohol, cannabis or cocaine dependency who were in treatment as usual . Measurements: Primary outcome measures: Substance use and craving. Secondary outcome measures: WMC, impulsivity, attention bias and psychopathology. Participants were assessed before and after 24 sessions of WM training as well as two months after the training.