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Bevacizumab Versus Corticosteroids as First-line Treatment in Patients With Symptomatic Cerebral Radiation Necrosis After Radiation for High-grade Glioma or Brain Metastases
Cerebral radiation necrosis (CRN) is a severe complication of high-dose radiation for brain metastases (BM) or glioma, which can potentially cause significant neurologic symptoms leading to serious morbidity and impaired quality of life (QoL). The first-line therapy for symptomatic CRN (sCRN) is corticosteroids, primarily dexamethasone, which often leads to complications, refractory symptoms, and interference with anti-cancer treatment. Since 2017, bevacizumab, an antibody against Vascular Endothelial Growth Factor (VEGF), has been used in a second-line treatment setting for refractory sCRN. A small randomized clinical trial (RCT) has shown that bevacizumab significantly...
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Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
This trial is set up as a prospective observational cohort study to identify if either biopsy or resection should be the surgical modality of choice in elderly glioblastoma patients with a newly diagnosed tumor. Patients who are considered eligible for GBM resection or biopsy will be included. Through shared-decision making patients and their treating physicians will decide upon resection or biopsy. Written informed consent will be obtained. Participants will be followed for 1 year postoperative to assess potential differences in health-related quality of life and overall survival. Follow-up will consist of health-related quality of life questionaires and neurological assessment...
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Bispecific T Cell Engager BRiTE for Patients With Grade IV Malignant Glioma
This phase 1 study will evaluate a novel hEGFRvIII-CD3-biscFv Bispecific T cell engager (BRiTE) in patients diagnosed with pathologically documented World Health Organization (WHO) grade 4 malignant glioma (MG) with an EGFRvIII (epidermal growth factor receptor variant III) mutation (either newly diagnosed or at first progression/recurrence). The primary objective is to evaluate the safety of BRiTE in such patients.
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Brain Areas of Cognitive Functions: a Study in Awake Surgery
This research project focuses on low-level cognitive functions such as perception (auditory, visual, etc.) and high-level cognitive functions (memory, language, temporal estimation, etc.). It aims to better understand the brain bases of these functions as well as their overlap (i.e., brain bases considered to be involved in different functions). To this end, various cognitive tasks will be performed before and during awake brain surgery, allowing us to determine the involvement of different areas in the task being performed. Comparing performance between the pre-test and the intraoperative test will help determine the potential involvement of the tested area.
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Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years
BICHE- 1: Brain Irradiation for Childhood cancer - Endocrine monitoring during the first five years is a study of endocrine monitoring after cerebral radiotherapy. The study concerns patients in remission at the end of oncological treatment aged between 4 and 18 years at the time of inclusion and who have had radiotherapy before the age of 16, irradiating all or part of the brain, with a delay between the end of radiotherapy and inclusion of less than 5 years. Patients will be included during a routine visit to the paediatric endocrinologist. The protocol for the Biche 1 study has been designed and discussed in a multidisciplinary and multicentre manner, based on data from the...
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Brain Tumor Surgery and Postoperative Delirium
1. To explore whether the combined administration of dexmedetomidine during and after surgery in patients undergoing brain tumor resection is an effective and safe modality to prevent postoperative delirium and improve sleep quality than giving it alone after surgery. 2. To explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can reduce postoperative acute pain and prevent chronic pain. 3. To explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can provide stable anesthesia depth,...
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Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure
This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of cadonilimab (AK104) in combination with anlotinib in the treatment of locally advanced or metastatic melanoma.
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CARDiac Toxicity Following ImmunOtherapy Treatment for Melanoma
People who develop a type of skin cancer known as 'melanoma' are often treated with immunotherapy. The type of immunotherapy used for patients with melanoma is known as Immune Checkpoint Inhibitors (ICI). While ICI is very successful, it can lead to negative side effects that are known as 'immune related adverse events' (irAEs). These irAEs can affect any part of the body and can range in severity from mild symptoms to death. There has been a lot of research on irAEs that occur during ICI, but less is known about how irAEs can affect people in the long-term. Although irAEs are common from ICI, acute irAEs affecting the heart (cardiac irAEs) are uncommon. However, as they...
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cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis
The goal of this clinical trial is to determine if cCeLL imaging is as accurate as standard biopsy practices for brain tumor surgeries. The main question[s] it aims to answer are: - Is it as accurate as standard biopsy practices? - Can it be performed faster than standard biopsy practices? Participants will consent to having their tumor tissue assessed by both cCeLL and standard biopsy procedures. There are no additional participation requirements beyond the tumor removal surgery.
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Cerebrospinal Fluid Cytology-guided Intrathecal Chemo-holiday Therapy for EGFR-positive NSCLC Leptomeningeal Metastases
With the rapid development of targeted drugs, the treatment of patients with leptomeningeal metastasis has become a very difficult problem in clinical work. High-dose targeted drugs and intrathecal chemotherapy are important treatment methods for meningeal metastasis. However, it is vital to note that safety is also of concern in previous studies of intrathecal chemotherapy. In this study, we aim to evaluate the safety and effectiveness of patient using chemo-holiday therapy based on the cerebrospinal fluid cytology, combined with double-dose EGFR-targeted drug in patients with leptomeningeal metastases from EGFR-positive NSCLC.