There are about 36633 clinical studies being (or have been) conducted in France. 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 goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.
Adenocarcinoma of the anus is rare. It concerns less than 10% of anal cancers and its incidence is less than 0.2/100 000 inhabitants. Its management is not consensual and is most often derived by analogy with that of adenocarcinoma of the lower rectum. This is due to the rarity but also to the diversity of anatomical (anal margin, anal canal, lower rectum), etiological (primary glandular tumors or secondary to anal fistula, primary distant tumor and/or Crohn's disease) and histological forms (mucinous, intestinal, glandular adenocarcinomas and primary or secondary Paget's disease). Most of the literature consists of small case series and simple clinical cases in which the prognosis of these subforms has not been studied.
Hip (THR) or knee (KT) prosthetic surgery is a bleeding surgery with an average blood spoliation of about 1 liter and an average decrease of about 3 g/dl in hemoglobinemia (Hb). Consequently, anemia is observed postoperatively in almost all patients (between 85% and 99% depending on the preoperative Hb value). In all cases, anemia-related events delay the patient's recovery, favor the occurrence of complications and prolong the length of stay. The immediate treatment of acute postoperative anemia is based on transfusion of red blood cells (RBCs). However, this presents several risks for the patient. The first is immediate and associated with the procedure: risk of error with ABO/Rhesus incompatibility, sepsis, pulmonary edema, etc. The second is a medium-term risk, with an increased risk of infection after prosthetic hip or knee surgery. In the long term, immediate postoperative blood transfusion is associated with higher mortality. In order to reduce the likelihood of a patient receiving RGCs, strategies have been developed within a "Patient Blood Management" (PBM), which could be translated as "Personalized Blood Transfusion Management". This strategy is based on 3 pillars: preoperatively, to ensure a patient's hemoglobin level of at least 13 g/dl; during the procedure, to limit blood loss; and postoperatively, to limit the indications for blood transfusion and the number of RGCs to the strict necessary. As the main determinant to trigger the prescription of a blood transfusion is the Hb value, the objective is that the lowest value of hemoglobinemia (Hb_nadir) postoperatively is as close as possible to 10 g/dl. The objective of this study is to describe, by means of the data available in the computerized patient record of patients undergoing scheduled THR or PTG operations at the Paris Saint Joseph Hospital, a prediction equation for Hb_nadir < 10 g/dl and, thus, to prescribe iron and ESAs only in patients who require them.
Cervical spine trauma is a frequent reason for consultation in emergency medicine. It concerns approximately 10,000 patients admitted to the emergency room each year in France. There are two types of cervical spine trauma: penetrating and non-penetrating. Non-penetrating injuries are the most frequent and can be classified according to the mechanism involved. Whiplash is the most common type of trauma in emergency medicine. The injuries associated with this type of trauma predominate in the mobile spinal segment and are most often benign: only 2 to 3% of conscious patients consulting the emergency room actually present with cervical injuries such as fractures, dislocations or unstable sprains. In emergency medicine, the paradigm is therefore to identify patients at risk of complications, minimizing the need for unnecessary and radiating imaging. Although cervical spine trauma is a frequent reason for emergency room visits, the incidence of anatomical lesions is generally low and the X-rays prescribed most often do not show any abnormality. For cervical lesion screening to be safe and effective, the screening rules must have a high sensitivity, a low negative likelihood ratio, and a low false positive rate. Two clinical prediction rules have been extensively evaluated in the literature to guide imaging for nonpenetrating cervical injuries: the National Emergency X-Radiography Utilization Study (NEXUS) rule and the Canadian C-Spine 5 rule. The NEXUS rule4 applies to any clinically stable patient (Glasgow Coma Scale 15, systolic blood pressure ≥ 90 mmHg, and respiratory rate between 10 and 24/min) presenting to the emergency department with a nonpenetrating trauma. The criteria constituting the NEXUS clinical rule are: - Absence of tenderness on palpation of the posterior cervical midline ; - Normal state of alertness (Glasgow Coma Scale 15); - Absence of focal neurological deficit; - Absence of signs of intoxication; - Absence of distracting pain (other pain that may mask neck pain, e.g., long bone fracture). If these 5 criteria are present, the risk of cervical spine injury is low and no imaging is recommended. The Canadian C-Spine 5 rule applies to patients who are 16 years of age or older; conscious with a Glasgow Coma Scale of 15; stable (systolic blood pressure ≥ 90 mmHg and respiratory rate between 10 and 24/min); and have had head or neck trauma in the past 48 hours. As soon as the rules of clinical prediction do not make it possible to rule out the hypothesis of a spinal injury, the exploration of cervical trauma traditionally involves the performance of radiographic images. They must include the following incidences: face, profile and open mouth centered on the cervico-occipital hinge ("open mouth odontoid"). Nevertheless, the sensitivity of these conventional radiographs for the detection of cervical spine lesions is poor, about 50%. Thus, the use of standard radiographs is usually limited to conscious, ambulatory patients at low risk of spinal injury. Conversely, the cervical CT is the reference examination for the detection of spinal bone lesions with a sensitivity close to 100%. Its sensitivity is superior to that of radiographic images in both high-risk and low-risk patients with spinal injuries. Difficulty of access and exposure to ionizing radiation, which is lower with standard radiography, generally influence the choice of imaging in the emergency room. In December 2020, the French High Authority for Health published a sheet on the relevance of cervical imaging in the context of non-penetrating cervical trauma. This sheet proposes a practical table according to the precise clinical context of the patient as well as the best first-line imaging. These good practice recommendations were part of an approach to improve the relevance of care. Cervical spine imaging for patients admitted to the emergency department for non-penetrating cervical spine trauma was recommended in one of the following situations - patient 65 years of age or older ; - patient unstable or with consciousness disorders or neurological signs; - imaging recommended by one of the following two rules: NEXUS or Canadian C-Spine; - a history of ankylosing spine (ankylosing spondylitis, hyperostosis, etc.), even in case of "minor" trauma; - if a cervical artery dissection is suspected. Investigator's hypothesis is that the HAS recommendations of good cervical imaging practices for non-penetrating cervical trauma are difficult to apply routinely in emergency departments for several reasons: the frequency of consultations for cervical trauma, the limited availability of emergency CT scans, and the fear of radiation and unnecessary additional costs in emergency situations. Investigators wish to determine the actual rate of application of the clinical rules recommended by the HAS in the GHPSJ emergency department and the factors predicting their non-application by the GHPSJ team of emergency physicians.
Metabolic steatopathy (nonalcoholic fatty liver disease or NAFLD) has seen its prevalence soar in recent years that it is now the leading cause of chronic liver disease in developed countries, surpassing viral and alcoholic etiologies and affecting approximately 25% of the world's population. This growth is explained by a change in eating habits, lifestyle, and the increase in the prevalence of obesity in the general population. This hepatopathy evolves in successive stages in a slow and insidious manner: from simple fatty overload in the liver (NALF, steatosis), to steatosis plus hepatic inflammation (NASH - "nonalcoholic steatohepatitis"), up to the stage of cirrhosis with all its own complications Isolated steatosis has a rather benign course, whereas the transition to NASH is associated with a high risk of general mortality and liver-related causes. NASH is the stage at which fibrogenesis accelerates with the risk of progression to cirrhosis and/or primary liver cancer. The degree of hepatic fibrosis has a major influence on the prognosis of patients with NAFLD. Specifically, the presence of fibrosis greater than or equal to 2 (F≥2) is associated with increased risk of liver events and liver-related mortality. The risk of cardiovascular events increases as early as fibrosis grade 1 (F≥1). In addition, the presence of advanced fibrosis or cirrhosis (F≥3) greatly increases the risk of developing hepatocellular carcinoma, and patients require biannual monitoring by liver ultrasound. Systematic screening of diabetic patients with advanced fibrosis is necessary to establish specific surveillance. Non-invasive scores have been developed to assess the degree of liver fibrosis in patients with NAFLD. Among these scores, FIB4 ("Score Fibrosis-4") has the advantage of being easy to use in routine practice with good diagnostic performance for liver fibrosis in patients with NAFLD. A FIB4 value ≤ 1.3 has a negative predictive value of 90% for the diagnosis of severe fibrosis (F≥3), whereas a FIB4 > 2.67 has a positive predictive value of 80% for severe fibrosis. Diagnostic performance is poorer for patients older than 65 years, and an FIB4 cutoff <2 is used in this case to identify those at very low risk of advanced fibrosis. This score is calculated from platelet count, patient age, and transaminases (ASAT: Aspartate-Amino-Transferase and ALAT: Alanine-Amino-Transferase) according to the following formula: (age x ASAT) / (platelets x √[ALAT]). It allows selection of patients with a higher risk of advanced fibrosis who will require further investigations and specialist advice. It also allows to avoid unnecessary explorations in patients with a low risk of advanced fibrosis (FIB4<1.3 if age<65 years or FIB4<2 if age>65 years). There is currently no pharmacological treatment with market authorization. The mainstay of treatment is a change in lifestyle and habits (dietary and behavioral, including increased physical activity) with the aim of "fat cleansing" the liver. There is a strong link between the presence of type 2 diabetes and the risk of developing NAFLD and/or NASH. NAFLD is present in 70% of patients with type 2 diabetes. Furthermore, the presence of diabetes is associated with an increased risk of developing advanced fibrosis, cirrhosis and hepatocellular carcinoma in patients with NAFLD. Glycation end products are substances that result from the reaction between a carbohydrate and protein residues, but can also result from lipid oxidation. These molecules have been associated with accelerated aging and increased risk of cardiovascular disease. The accumulation of glycation end products during periods of prolonged hyperglycemia seems to contribute to the progression of hepatic fibrosis. In this context, our study aims to evaluate the impact of type 2 diabetes control on the degree of liver fibrosis using non-invasive tests. The primary objective is to evaluate the association between diabetic disease control and the degree of liver fibrosis. The secondary objectives are: to evaluate the practices in terms of evaluation of hepatic fibrosis and management of diabetic patients at risk of advanced fibrosis in a tertiary diabetes service, to evaluate the association between the use of certain treatments and the degree of hepatic fibrosis, to evaluate the impact of the variation of the Body Mass Index (BMI) on hepatic fibrosis and to evaluate the percentage of patients at risk of severe fibrosis in a population of type 2 diabetic patients followed up in a tertiary diabetology service.
Antibiotic prophylaxis in the operating room reduces the frequency of occurrence of surgical site infections (SSI) by preventing bacterial proliferation. The main antibiotic used in all surgery is CEFAZOLINE. This antibiotic of the Beta-lactam family, and more precisely of the 1st generation cephalosporins, is active on a specific bacterial target, which is often the cause of surgical site infections. Patients known to be allergic to penicillin have a 50% higher risk of surgical site infection. The choice of antibiotic prophylaxis often comes up against the risk of allergy in anesthesia. In France in 2004, according to the INSERM database, 100 IgE-mediated immediate hypersensitivity reactions (IHR) were observed out of 1 million anesthesias. The attributable allergens in descending order were curares (60.6%), latex (5.2%) then antibiotics (18.2%), followed by dyes (3.5%), hypnotics, opioids, gelatins and local anesthetics were rarely found. Regarding allergy to antibiotics, the leading antibiotic for allergy in France is AMOXICILLIN, which accounts for 29% of drug-induced anaphylaxis. In view of the risk of cross-allergy, a history of allergy to AMOXICILLIN in the operating room is a contraindication to all beta-lactam antibiotics and therefore leads to an alternative choice to CEFAZOLINE when the latter was indicated for first-line antibiotic prophylaxis. However, this choice of alternative antibiotic to CEFAZOLINE is not without consequences. First of all, the alternative antibiotics Vancomycin and Clindamycin have a narrower spectrum and therefore may not cover all germs found in SSI. They do not cover Gram-negative organisms for Vancomycin and Gram-negative aerobes for Clindamycin. Moreover, the use of these antibiotics exposes to undesirable effects. They can promote the occurrence of nosocomial infections such as Clostridium difficile colitis, infections with resistant germs such as methicillin-resistant Staphylococcus aureus (MRSA) or Vancomycin-resistant Enterococcus (VRE). Other adverse effects may occur such as Nephrotoxicity and Red Man Syndrome with Vancomycin. In addition, these antibiotics may be more difficult to handle, not allowing for the optimization of recommended delivery conditions. Secondly, the notion of the cost of these antibiotics must be taken into account. Two elements could encourage investigators to use CEFAZOLINE despite a history of allergy to AMOXICILLIN. 1. 1. Allergy declarations such as can be obtained in consultation correspond mainly to false positives. In fact, out of 10% of the world's population reporting an allergy to penicillins, only 1 to 2% of subjects have a proven allergy. In GHPSJ, among the patients consulting for a suspected allergy, the reintroduction test confirmed it in only 5.6% of them. 2. From a molecular point of view, there is a low rate of similarity between these two molecules. Contrary to popular belief, cephalosporin allergy is not mediated by the β-lactam core. The cross-allergy between cephalosporins and penicillin comes from the similarities of the R1 chain which is attached to the β-lactam nucleus at position 7 for cephalosporins, at position 6 for penicillins. This may therefore explain the lack of clinical cross-reactivity. The primary objective is to evaluate the proportion of patients of allergies between CEFAZOLINE and AMOXICILLINE. The secondary objectives are to evaluate the diagnostic value of skin tests to CEFAZOLINE and to describe the safety of protocol of reintroduction of CEFAZOLINE and AMOXICILLINE in the context of IgE-mediated cross-reactivity.
The primary objective of this study is to obtain prospective baseline documentation of annualized bleeding rates (ABRs) and treatment under standard-of-care (SOC) therapy among participants with hemophilia A or B. Participants in the study may be eligible to enroll in future planned interventional studies to be conducted by Sponsor.
This study is a multicenter, open-label, proof-of-concept study aiming to assess the clinical and biological impact of NP137 when added to standard PD-1/PD-L1 blockade therapy in 3 independent cohorts of advanced or metastatic solid tumors with various sensitivity to anti-PD-1/PD-L1: - Cohort 1 [Stable Disease]: Patients with a radiological documentation of SD according to RECIST V1.1 criteria following at least 12 weeks under standard anti PD-1/PD-L1 therapy. - Cohort 2 [primary refractory]: Patients with documented radiological PD according to RECIST V1.1 but with clinical benefit under anti PD-1/PD-L1 standard therapy. - Cohort 3 [secondary refractory]: Patients with documented radiological PD following an initial Objective Response according to RECIST V1.1, with clinical benefit under standard anti-PD-1/PD-L1.
Treatment of chronic myeloid leukemia (CML) has been revolutionized by tyrosine kinase inhibitor (TKI). Nevertheless, case of failure and suboptimal response are still observed even in children. Pediatric CML is a rare disease and differs from adult in terms of disease presentation and treatment response underlying a likely different CML biology. Molecular mechanisms that induce resistance to TKI are still poorly characterized except mutations in the tyrosine kinase domain of BCR::ABL1. We propose to search for a molecular signature to predict the response to TKI in the pediatric population.
Bronchopulmonary cancer is the first cause of mortality in the world. We want to update the margins used in stereotactic radiotherapy, in the context of localized lung cancer, of non-surgical management. The investigators wish to redefine the stereotactic radiotherapy margins according to the histological type in localized non-small cell lung cancer. Indeed, these criteria were previously defined on a smaller cohort, in the context of 3D radiotherapy (mainly T3, T4 tumors). In addition, the incidence of radiation pneumonitis is highly dependent on the irradiated lung volume, which in turn depends on the CTV margins used.