There are about 13174 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.
The aim of this study is to assess pain response after combining stereotactic body radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of painful unstable metastases of the thoracic and/or lumbar spine.
The purpose of the study is to evaluate safety and tolerability of JNJ-70075200 compared with placebo after administration of single ascending doses of JNJ-70075200 as oral solution (Part 1); multiple ascending doses of JNJ-70075200, administered as oral solution over 14 consecutive days (Part 2); and the option of a single dose of JNJ-70075200 administered as an oral solid formulation (Part 3).
The availability of antiretroviral therapy (cART) for HIV-1 infection has led to a reduction in morbidity in patients with chronic HIV infection. However, cART does not eliminate HIV-1 that persists as a latent infection in cellular reservoirs. Usually, HIV viremia rapidly rebounds if antiretroviral therapy is interrupted. Consequently, HIV infected individuals must commit to expensive, life-long therapies and must tackle problems associated with chronic infection and uninterrupted cART, including continuous clinical and laboratory monitoring, drug toxicities, and chronic immune activation/inflammation. Currently, there is an emerging interest in developing safe and affordable curative strategies that would eliminate the need for lifelong therapy. However, to date only allogeneic hematopoietic stem cell transplantation (allo-HSCT) has shown results in decreasing the HIV-1 reservoirs. The IciStem Consortium (www.icistem.org) has assembled the largest and most exhaustive observational cohort for the study of HIV reservoir dynamics in allo-HSCT HIV+ individuals with severe hematological malignancies worldwide. Within the cohort, only individuals transplanted with a donor with thw CCR5A32 mutation have shown signs of HIV remission. On the other side broadly neutralizing antibodies (bNAbs) have shown the potential to control HIV infection. This study intends to evaluate if the allo-HSCT combined with the additional application of bNAbs is effective to control HIV replication.
In people with type 2 diabetes (T2D), the body makes insulin, but cannot use it well. This results in high blood sugar levels causing damage to the blood vessels inside the kidneys. High blood pressure is a common condition that can cause damage to the blood vessels and heart if it is untreated. High blood pressure is also known as hypertension. Patients with type 2 diabetes (T2D) or high blood pressure are at a higher risk of having chronic kidney disease (CKD). In people with CKD, the kidneys become damaged and do not work as they should. Over time, the function of the kidney declines more, and this can lead to the requirement for dialysis or kidney transplantation. Most people with CKD are also at risk of heart conditions, such as heart attack or stroke. In this trial, the researchers want to learn if BAY2327949 reduces the amount of protein in the participants' urine. Protein in the urine is one of the signs of CKD. The researchers will compare the effects of BAY2327949 to a placebo. A placebo looks like the study drug but does not have any medicine in it. BAY2327949 is assumed to increase the blood flow through the kidneys, which may slow down the worsening of the disease. The researchers will use a placebo to learn if the changes seen in the participants are due to BAY2327949 or if the results could be due to chance. This trial will include about 120 men and women over the age of 45 who have CKD. The participants will have T2D or high blood pressure, and a further disease of the heart or blood vessels. During the trial, the participants will take either BAY2327949 or a placebo once a day for 28 days. The participants will visit their trial site about 9 times during the trial, and need to provide urine samples to check the participants' CKD symptoms. At the visits, the doctors will ask them if they have any health problems. They will also take blood samples to perform laboratory assessments.
Rationale: The rapidly increasing number of elderly (≥ 65 years old) with traumatic brain injury (TBI) is accompanied by substantial medical and economic consequences. An intracranial hematoma, specifically an acute subdural hematoma (ASDH), is the most common injury in elderly with TBI. The surgical versus conservative treatment of this patient group remains an important clinical and moral dilemma, since it is in most cases unclear which treatment leads to a better outcome for the patient. Current guidelines are not based on high-quality evidence and compliance is low, allowing for large treatment variation in both Belgium and the Netherlands for patients with a traumatic ASDH. In addition, elderly are underrepresented in scientific TBI literature and are therefore not included in current guidelines or prognostic models, leading to major uncertainty in (neurosurgical) decision-making for this group. As participants in two large TBI research projects (CENTER-TBI, Net-QuRe), the investigators observe that the uncertainty regarding treatment of elderly with a traumatic ASDH will not be solved by the current ongoing studies. Therefore, they recognize the necessity of undertaking a prospective, randomized, multicenter trial on the (cost-)effectiveness of early surgical hematoma evacuation versus a conservative treatment in elderly with a traumatic ASDH. Objective: To compare the (cost-)effectiveness of early surgical hematoma evacuation versus a conservative treatment in elderly patients with a traumatic ASDH. Study design: A prospective, pragmatic, multicenter, randomized controlled trial (RCT). Study population: Patients ≥ 65 years with at first presentation a GCS ≥ 9 and a traumatic ASDH >10 mm or a traumatic ASDH <10 mm and a midline shift >5 mm, or a GCS < 9 with a traumatic ASDH <10 mm and a midline shift <5 mm without extracranial explanations for the comatose state, for whom clinical equipoise exists regarding the preferred treatment. Intervention: Patients are randomized to either early surgical hematoma evacuation (A) or conservative management on the ICU or the ward (B). In case of neurological deterioration during conservative management, delayed surgery can be performed. The exact neurosurgical technique will be left to the discretion of the surgeons. Main study parameters/endpoints: Functional outcome after 1 year, expressed by the rating on the Extended Glasgow Outcome Scale (GOS-E) Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both treatment strategies are already used in current clinical practice as standard medical care. Therefore, there are no extra risks for patients participating in the study compared to patients outside the study. Study participation adds a minimal burden of three follow-up evaluations by visit in the first year (at 3, 6 and 12 months) and subsequent yearly evaluations by phone or postal until five years after the injury. Future elderly patients with a traumatic ASDH will benefit mostly from this study's results.
Cetuximab to reduce the amound of circulating tumor cells in early stage NSCLC
Risk of contrast-induced kidney injury is expected to be strongly correlated with exposure time. Studies on the excretion of iodinated contrast material are few and have mostly been carried out in patients with normal renal function. Although case wise reports of persistent renograms have been published, it is not known how long contrast is retained before excretion in patients with eGFR <30 mL/min/1.73m2, nor which of these patients are most susceptible to contrast retention. The current observational study aims to compare contrast elimination time and % contrast excretion in patients with eGFR <30 mL/min/1.73m2, to matched patients (for age, sex and contrast procedure type) with eGFR 30-59 and eGFR >=60 mL/min/1.73m2.
Intravascular iodinated contrast administration has become crucial to modern medicine. Currently it is estimated that over 250 million injections are given each year worldwide during medical scans and interventions. An acute predefined increase in serum creatinine is considered an indicator of acute kidney injury (AKI). When such an acute increase in serum creatinine occurs within 5 days post-contrast in absence of another aetiology, it is assumed to be iodinated contrast administration induced acute kidney injury. For over 50 years now, acute kidney injury caused by intravascular administration of iodinated contrast material has been considered a leading cause of hospital-acquired renal failure. Contrast has been withheld in fear of kidney injury with misdiagnoses and delayed appropriate patient management as a result. Since 2018, it is now widely accepted that only patients with eGFR <30 mL/min/1.73m2 are at risk of renal injury after intravascular iodinated contrast material injection. However, no study to date has been able to distinguish acute kidney injury caused by iodinated contrast administration from that for which no causal link is established, and it is unsure a causal relationship exists. There are several studies, in attempts to evaluate the causal relationship between contrast exposure and nephrotoxicity, that found fluctuations in absence of contrast similar to those considered to be contrast-induced acute kidney injury. Similarly, it is unsure whether longer-term negative outcomes are inherent to the population studied or a result of contrast administration. However, most of these studies are observational and retrospective in nature. The issue with retrospective studies is that they often cannot control for confounders and therefore cannot give us causation, only association. On the other hand, prospective randomized controlled trials comparing intravascular iodinated contrast administration to no contrast are unlikely given evident ethical issues. The current prospective observational study proposes to use intra-patient comparisons of peak change in renal function during periods in absence of- and with contrast to elucidate the relationship between renal function and contrast administration in this population.
Point-of-care (POC) creatinine devices allow rapid measurement of creatinine levels and calculation of estimated glomerular filtration rate (eGFR) which give an indication of renal function. The focus of this assessment is to validate POC measurements to assess kidney function before intravascular iodinated contrast administration in patients with severe renal insufficiency (eGFR < 30 ml/min/1.73m2). It will be evaluated whether discrepancies between POC measurement values and values obtained from standard laboratory assays lie within an acceptable range using Bland-Altman analysis.
The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.