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.
Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor lesions in breast cancer patients is essential for diagnostic and therapeutic management of metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional information, have so far not been able to replace the biopsy. To solve this problem, non-invasive whole body visualization and quantification of HER2 expression by means of the HER2-PET may be a valuable tool. In this prospective multicenter imaging study, eligible patients will receive one HER2-PET and CTC analysis in addition to standard work up for metastatic disease. Subsequent administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three questionnaires, one before HER2-PET and two after HER2-PET.
The primary objectives of this study are as follows: - To assess the safety and tolerability of escalating single and multiple doses of GS-5745 (andecaliximab) in participants with moderate to severe ulcerative colitis (UC) as assessed by adverse events (AEs) and laboratory abnormalities - To assess the pharmacokinetics (PK) of GS-5745 (andecaliximab) in participants with moderate to severe UC.
In two sessions of four days nurses will be exposed to dynamic lighting and normal (reference) lighting. Through the psychological tests T.O.D.A. (Test or divided attention) and T.O.S.S.A. (Test of sustained selective attention), then the focus tested. These two tests run both 5 times. The investigators also ask to fill out: 3 questionnaires, fatigue and mood, sleep and Questions of Life.
Quality of life and patient satisfaction are two important concepts in health care, especially in chronic diseases. Currently, there are several instruments available to determine this, but many are not easily applicable in daily practice because of their length and the consequential effort they require from both patients and caregivers. In the UK, Benson et al. recently developed two short generic patient questionnaires on quality of life and patient satisfaction: the howRu and howRwe questionnaires. Both questionnaires contain four items. The howRU questionnaire has already been validated and seems highly applicable to be used in large patient groups. The howRwe questionnaire has not been validated yet. The reliability of both questionnaires has not been assessed either. The procedure as suggested by Kocks et al. provides us with the opportunity to perform a reliability procedure on patient level. The purpose of this study is to assess the reliability of the howRU and the howRwe questionnaires on patient level in the Dutch population.
The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).
Chronic pain after Lichtenstein hernioplasty is a common problem with an incidence of 11%. Many factors influence the onset and persistence of pain. Mesh characteristics and fixation have been pointed as important etiologic factors. This study compares two types of fixation for the same mesh. The mesh used is a lightweight parietex mesh. In the control group this mesh will be fixed with non absorbable sutures. In the study group sutures will not be needed because of self gripping microhooks on the surface of the mesh. Methods: The HIPPO trial is a multicenter double blind randomized clinical trial. Patients will be randomly allocated to the sutured mesh or the self-gripping mesh. Hernia repair will be done according to Lichtenstein as described by Amid et all. Included will be all unilateral primary inguinal hernia in man patients aged 18 years or older not meeting the exclusion criteria. Patients will be followed for two years. The main endpoint is the amount of post-operative chronic pain evaluated by VAS scores. The existence of neuropathic pain will be evaluated by the Paindetect questionnaire (and a bedside variant of the QST). Secondary endpoints are recurrence rate, post-operative complications, costs, hospital stay, QOL, return to work and daily activities, genital and sexual problems. To demonstrate a difference in VAS score of 10 with α=0.05 and power 80% a sample size of 400 patients is calculated. Discussion: Hypothesized is that the self gripping non-sutured mesh (Parietex Progrip) will cause less post-operative and chronic pain without enhancing the recurrence rate.
Due to limited experience with cabazitaxel in TCCU, the study will be started as a randomised phase II study. The aim of the phase II study is to evaluate if the response rates (CR + PR) are sufficiently high to further study the treatment regimens in a phase III setting.
Background: It is widely recognised that spiritual care plays an important role in physical and psychosocial well-being of cancer patients but there is little evidence based research on the effects of spiritual care. The investigators will conduct the first randomized controlled trial on spiritual care using a brief structured interview scheme supported by an e-application. The aim is to examine whether an assisted reflection on life events and ultimate life goals can improve quality of life of cancer patients. Design: Based on the findings of the investigators previous research, the investigators have developed a brief interview model that allows spiritual counselors to explore, explicate and discuss life events and ultimate life goals with cancer patients. To support the interview, the investigators created an e-application for a PC or a tablet. To examine whether this assisted reflection improves quality of life the investigators will conduct a randomized trial. Patients with advanced cancer not amenable to curative treatment options will be randomized to either the intervention or the control group. The intervention group will have two consultations with a spiritual counselor using the interview scheme supported by the e-application. The control group will receive care as usual. At baseline and one and three months after randomization all patients fill out questionnaires regarding quality of life, spiritual wellbeing, empowerment, satisfaction with life, anxiety and depression and health care consumption. Discussion: Having insight into one's ultimate life goals may help to cope with a life event such as cancer. This is the first randomized controlled trial to evaluate the role of an assisted structured reflection on ultimate life goals to improve patients' quality of life and spiritual well being. The intervention is brief and based on concepts and skills that spiritual counselors are familiar with, it can be easily implemented in routine patient care and incorporated in guidelines on spiritual care.
One interesting approach to the treatment of addiction is the use of Eye Movement Desensitization and Reprocessing (EMDR) (Shapiro, 1989). Although research on the feasibility and efficacy of EMDR on addiction is limited and often lacks methodological rigor, the results are promising and suggest that further research on this subject is warranted. This proposal consists of two studies to test and determine the acceptability, feasibility and efficacy of EMDR as an intervention to reduce craving and alcohol use in alcohol dependent outpatients as well as to gain further understanding in underlying working mechanisms.
This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy. Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.