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.
Rationale: There is some information suggesting that a progesterone-induced withdrawal bleeding before the start of ovulation induction in women suffering from oligo- or amenorrhea reduces pregnancy and live birth rate. Objective: To evaluate the effects of withholding progesterone-induced endometrial withdrawal bleeding before ovulation induction on the time to pregnancy and the ongoing pregnancy rate. Study design: Prospective multicenter randomized controlled feasibility study Study population: Women with oligomenorrhea or amenorrhea according to WHO classification category 2 Intervention: Patients will be randomized to receive one of the following two treatments: Stair step group: blind start ovulation induction (no progesterone induced withdrawal bleeding and stair step protocol in case of treatment failure. Control: standard care; a progesterone induced withdrawal bleeding in case of no spontaneous menses before starting an ovulation induction cycle and in between anovulatory cycles. Main study parameters/endpoints: The primary endpoints are the time to pregnancy and ongoing pregnancy rate within a treatment horizon of 3 cycles. Secondary endpoints include time to ovulation, endometrial thickness, multiple pregnancy and the incidence of treatment failure. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The number of site visits or physical examinations will not differ from accepted clinical practice.
The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have responded inadequately to 2 to 4 classes of prior preventive treatments. Approximately equal numbers of participants from each subgroup (CM and EM) are randomized in blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1 placebo treatment- consisting of monthly injections for 3 months (up to Week 12). Then all participants continue into an open-label extension of 3 months (up to Week 24) during which everyone is administered sc injections of fremanezumab.
Rationale: 30-70% of comatose patients admitted to the intensive care unit (ICU) after cardiac arrest never regain consciousness as a result of post anoxic encephalopathy (PAE). Early identification of patients without potential for recovery of brain functioning may prevent inappropriate continuation of medical treatment and improve communication between doctors and patients. However, current diagnostic and prognostic measures can identify only 20-50% of the patients with irreversible brain damage, precluding cerebral recovery and awakening. Also, the pathophysiology of brain damage is largely unclear. New magnetic resonance imaging (MRI) sequences hold potential to substantially improve outcome prediction. Objectives: 1. To estimate the additional value of early MRI monitoring for the prediction of neurological outcome of comatose patients after cardiac arrest. 2. To gain insight in the pathophysiology of PAE by associating MRI findings with histopathological studies of brain tissue obtained from non-survivors. Study design: prospective cohort study. Study population: 100 subsequent comatose patients after cardiac arrest, admitted to the ICU. Intervention: In addition to standard treatments, patients will undergo MRI of the brain at day 3, 7, and three months after cardiac arrest. A subgroup of patients will be scanned within 24 hours after cardiac arrest, to assess feasibility and to gain more insight in the evolution of brain damage in PAE. Survivors will be followed for one year. Outcome measurements will focus on disabilities, quality of life, and depression. MRI measures will be related to outcome. Main study parameters/endpoints: The primary outcome measure is neurological outcome, defined as the score on the Cerebral Performance Category (CPC) at six months, dichotomized as good (CPC 1-2 = no or moderate neurological disability) or poor (CPC 3-5 = severe disability, coma, or death). Secondary outcome measures include cognitive functioning, depression, and quality of life at one year, as well as histopathological damage of brain tissue of non-survivors.
Rationale: For patients with perihilar cholangiocarcinoma, surgery is the only treatment modality that can result in cure. Unfortunately, in the majority of these patients the tumors are found to be unresectable at presentation due to local invasive tumor growth or the presence of distal metastases. For patients with unresectable cholangiocarcinoma palliative chemotherapy is the standard treatment yielding an estimated median overall survival of 12-15.2 months. There is no evidence from randomized trials that support the routine use of stereotactic body radiation therapy (SBRT) for cholangiocarcinoma. However, small and most often retrospective studies combining chemotherapy with SBRT showed promising results with overall survival reaching up to 33-35 months. Based upon these observations, the investigators designed a local feasibility trial with SBRT after chemotherapy in patients with unresectable perihilar cholangiocarcinoma in order to try to confirm the observed tolerability of adding SBRT to standard chemotherapy. The expected time to include the required patients for this pilot study will be one year. Objective: To assess feasibility of SBRT as add on treatment after standard chemotherapy. Study design: Local feasibility trial. Study population: Patients diagnosed with perihilar cholangiocarcinoma, 18 years of age or older, T1-4 N0-1 M0 (AJCC 7th Edition), after completion of standard chemotherapy. Exclusion criteria are local tumor growth into either stomach, colon, duodenum, pancreas or abdominal wall. Sample size will be 6 patients. Intervention: SBRT will be delivered in 15 fractions of 3 to 4.5Gy after 8 cycles of chemotherapy. In case of toxicity causing premature termination of systemic treatment, the patient can still proceed to SBRT. Main study parameters/endpoints: The primary endpoint of this study is feasibility measured by radiotherapy induced toxicity according to CTC v4.0.3. Secondary endpoints will be: - Quality of life - Local progression - Progression free survival - Overall survival - Cellular radiosensitivity.
Rationale: Supportive care such as physical therapy, psycho-social education, and dietary advice is likely to have a positive effect on the recovery and quality of life of cancer patients. Currently, not all patients know how to access supportive care, which results in unmet supportive care needs. This study determines whether these unmet needs can be reduced or prevented by a patient navigation intervention that focuses on timely screening and systematic monitoring of patient's supportive care needs. Objective: The primary objective is to determine the effect of patient navigation on health related quality of life. Secondary objectives are: 1) to determine the effect of patient navigation on satisfaction with, need for, and consumption of (supportive) cancer care; 2) to determine the effect of patient navigation on patients' self-management; 3) to explore how patient navigation affects the cost-effectiveness of cancer care. Study design: Longitudinal randomised controlled trial with two study arms: a patient navigation intervention and care as usual. Study population: Newly diagnosed lung, melanoma, urology, or gynecology patients of the Netherlands Cancer Institute. Intervention : Consultations with a specifically trained oncology nurse (i.e. patient navigator), who assesses patients' needs for supportive cancer care, provides information on supportive cancer care, and guides patients through the supportive cancer care system. Consultations with the patient navigator take place at the start, halfway through, and at the end of treatment. Main study endpoints: The main endpoint of this study is health related quality of life, which is defined as an individual's perceived emotional, social, physical, and functional wellbeing over time. Health related quality of life is assessed with the EORTC QLQ-C30. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants are expected to strongly benefit from consulting the patient navigator without being subjected to any severe risks. Consultations will be provided by highly qualified professionals, and result in benefits such as decreased severity of cancer-related psychosocial and physical distress. To minimise burden, face-to-face consultations will always be scheduled alongside other appointments of at the NKI-AVL. Furthermore, questionnaire completion takes no more than 30 minutes per data collection round, of which three are scheduled in this study.
Rationale: Seroma formation and its sequelae form the mainstay of complications in breast cancer surgery. Seroma has an incidence of 3% to 85%. Complications vary from delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic. The key to reducing seroma formations seems to partly lie in the obliteration of dead space. The use of electrocautery has been demonstrated to increase seroma formation following mastectomy, however no other surgical devices (laser scalpel, argon diathermy and ultrasonic scalpel) or substances have proven to be superior in seroma reduction. No prospective randomized controlled trials have been able to demonstrate which techniques are superior in reducing seroma and as a consequence patient discomfort in patients undergoing mastectomy. In a previous retrospective observational study these investigators demonstrated that mastectomy flap fixation significantly reduced seroma formation and the number of seroma aspirations. In a pilot study that was recently performed in one of the investigators hospitals, ARTISS tissue glue was used for skin flap fixation and showed promising results. The investigators hypothesize that obliteration of the dead space following mastectomy will significantly reduce seroma formation, its complications and the discomfort it causes patients undergoing mastectomy.
The investigators will develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls). On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, they will further optimise the model using reinforcement machine learning. The model will then be validated in 300 prospective patients.
This is a single-center, phase I study consisting of 2 parts. The first part is a multiple ascending dose (MAD) part with a randomized, double-blind, placebo-controlled design in 3 treatment groups of 8 subjects (6 active; 2 placebo). The second part is a food effect (FE) part with a randomized, open-label, 2-period, 2-way crossover, single dose design in 8 subjects.
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy of VX-150 for the treatment of pain caused by small fiber neuropathy.
After renal transplantation 5 to 10% of patients experience allograft rejection. Rapid and accurate diagnosis is vital for implementation of additional immunosuppressive therapy. Currently, a renal biopsy is essential for the diagnosis of renal allograft rejection. However, this is an intervention associated with complications like bleeding, patient discomfort and hospital admission. Additionally, limited biopsy sample size may lead to false negative results. So, the introduction of a new non-invasive diagnostic tool for allograft rejection could have major implications for the care of renal transplant recipients. For the purpose of visualizing infiltrating T lymphocytes with positron emission tomography (PET), the tracer 18-Fluor-Interleukin-2 ([18F]FB-IL2) has been developed. The investigators hypothesized that a high correlation exists between [18F]FB-IL2 uptake and the extend of T cell infiltration into renal transplants with signs of rejection