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.
Among Enterobacteriaceae, the production of beta-lactamases (ESBLs) is the leading cause of multi-resistance. The first cases of ESBL-producing Enterobacteriaceae (E-ESBL) infections were described in the 1980s and subsequently experienced worldwide dissemination. Since the turn of the century, the prevalence of E-ESBL infections, especially among Escherichia coli (E. coli) and Klebsiella pneumoniae (K. pneumoniae) has increased dramatically. The emergence of multidrug-resistant Enterobacteriaceae is currently a real public health problem. The European Antimicrobial Resistance Surveillance Network evaluated, among clinical strains, the rate of resistance to 3rd generation cephalosporins (C3G) at 9.5% for E. coli and 28% for K. pneumoniae. Numerous studies have shown that bacterial colonization is the prerequisite for the occurrence of many infections. However, the existence of prior colonization does not seem to be the only risk factor for the occurrence of a secondary infection. Therefore, in patients with multidrug-resistant Gram-negative bacillus gastrointestinal carriage there appear to be factors associated with the onset of infection. Several studies have examined the risk factors associated with E-ESBL-related infections in both community-based and healthcare-associated / nosocomial infections. Two main risk factors seem to be associated with E-ESBL infections: prior antibiotic therapy and the existence of invasive devices. A recent study, carried out on 1288 patients and aimed at validating a predictive score for the occurrence of ESBL-E bacteremia, demonstrated 5 factors associated with the appearance of E-ESBL-linked bacteremia. These factors were: (i) a history of colonization / infection with ESBL-E, (ii) age ≥ 43 years, (iii) recent hospitalization in a region with a high prevalence of ESBL-E, (iv) antibiotic therapy ≥ 6 days in the previous 6 months and (v) the existence of a chronic vascular access. Recently, a retrospective case-control study conducted in the United States by Augustine et al. Suggested that 5% of cases of bacteremia were related to ESBL-E. Few studies have looked at risk factors for infection in patients known to be colonized by the digestive system. In a retrospective case-control study, conducted outside the intensive care unit and including pediatric and adult patients, the authors identified 2 factors associated with the occurrence of Ec-ESBL infection in previously colonized patients. These two factors were the prior use of antibiotics with β-lactam antibiotics and β-lactamase inhibitor (s), and urinary catheterization. In intensive care hospital patients, the occurrence of ESBL-producing enterobacteriaceae infection appears to be a rare event, including in colonized patients. The work of Ruppé et al. showed a direct link between relative fecal abundance of EScher-producing Escherichia coli and prior antibiotic intake. This work also demonstrated a link between the value of the relative fecal abundance in Ec-ESBL and the occurrence of a urinary tract infection linked to the same clone. In particular, the authors found that women with a low relative fecal abundance rate (≤ 0.1%) had no risk of developing an Escherichia coli urinary tract infection. Conversely, the risk increased with the relative fecal abundance of Escherichia coli, but with a positive predictive value limited to 57% for relative fecal abundances between 10 and 100%.
The MeDIAGSTOLE project aims to develop diagnostic tools for heart failure with preserved ejection fraction (IC / FEp), a pathology that is difficult to diagnose and to manage clinically in the absence of targeted treatment . The IC / FEp concerns the elderly population with comorbidities such as hypertension, obesity, anemia and atrial fibrillation. In the absence of specific biomarkers, clinical diagnosis is based on serum markers of heart failure with reduced ejection fraction (IC / FEr). The identification of new biomarkers, genetic and / or cellular, specific for IC / FEp would be an important innovation.
The propias, and more recently the update of the recommendations relating to the control of the spread of bacteria highly resistant to emerging antibiotics issued by the High Council of Public Health (December 2019), recommend the implementation of measures to maintain the rate of Carbapenemase-producing Enterobacteriaceae (EPC) such as Klebsiella pneumoniae (K. pneumoniae) isolated from bacteremia in healthcare establishments in France at less than 1%, and that of Vancomycin Resistant Enterococcus (VRE) belonging to Enterococci Resistant to Glycopeptides (ERG) such as Enterococcus faecium isolated from bacteremia in health establishments in France at less than 1% also. At the same time, the prevalence of colonized patients is increasing. One of the recommended measures concerns the fight against cross transmission. Due to the high technicality of the treatments, the risks of cross-transmission are very high and present at each stage of the dialysis procedure. Screening and isolation of patients colonized with emerging Highly Resistant Bacteria (BHRe) is essential to avoid their spread and the risk of infection with these germs. Screening is done using rectal swabs. If the patient is found to be a carrier of BHRe, he should be isolated. Isolation is made more difficult in the hemodialysis room due to their architectural configuration, the organization of care and the chronicity of the patients. Patients have a monthly sample. The isolation is allowed after obtaining six consecutive negative rectal swabs, the number of which has been arbitrarily defined. Indeed, the negativation of the samples does not confirm the disappearance of the carriage (that is to say the presence of BHRe), hence the need to repeat them. Persistence of colonization at a rate below the detection limit is possible. With for corollaries: - Isolation which could be lifted more quickly in the event of real disappearance of the strain since the investigators know that a prolonged period of isolation can lead to a loss of opportunity for the patient and the investigators know its impact for the patient, on the operation of the service and its cost, with in particular the increase in withdrawals. - Isolation lifted too early in the event of persistent carriage with risk of secondary transmission. The interest of this study is to determine the clearance of the carriage of BHRe, i.e. their disappearance, in the chronic dialysis patient and to define, secondly, the factors associated with the prolonged carriage corresponding to the presence of bacteria for more than 3 months. , and elements of answer concerning the early disappearance of the EPC in the event of co-colonization by ERG and EPC. The follow-up of this carriage for 1 year will make it possible to evaluate the relapse corresponding to the reappearance of the bacteria previously identified, the recolonization corresponding to the acquisition of a new BHR, or the reinfection corresponding to an infection with a new highly resistant bacterium.
This study aims to evaluate the efficacy of single agent loncastuximab tesirine compared to idelalisib in participants with relapsed or refractory follicular lymphoma.
The occurrence of arterial oxygen desaturation (hypoxemia) during the induction of general anesthesia remains one of the main causes of complications and mortality in anesthesia. In a healthy patient breathing in ambient air [Inspired O2 fraction (FiO2) = 21%] before the onset of narcosis, a drop in arterial O2 saturation (SpO2) occurs within 1 to 2 minutes. When pre-oxygenation is performed for 3 minutes in healthy subjects with FiO2 = 100%, SpO2 is less than 97% after 7.9 minutes of apnea and arterial O2 desaturation (SpO2 <93%) occurs after 8 to 9 minutes. For this reason and "in order to prevent arterial desaturation during tracheal intubation or supraglottic device insertion maneuvers", it is recommended "to systematically perform a pre-oxygenation procedure (3 min / 8 deep breaths) , including in the context of an emergency ". Tolerance to apnea is conditioned by the amount of O2 stored during the pre-oxygenation phase. Oxygen is transported to different tissues in 2 forms: combined with hemoglobin (Hb) and in dissolved form. In ambient air, the quantity of O2 transported by the Hb is much greater than the part transported in dissolved form. However, when the patient breathes a gas enriched in O2, all the molecules of Hb are quickly saturated (SpO2 = 100%), while the content of dissolved O2 increases constituting a reserve allowing to increase the tolerance to apnea. Under usual conditions (3 minutes pre-oxygenation with FiO2 = 1), tolerance to apnea is shorter in obese subjects. Arterial O2 desaturation occurs after 2-3 minutes of apnea in patients with grade III obesity [Body Mass Index (BMI)> 35 kg / m2]. In addition, arterial O2 desaturation is faster the higher the BMI is. In fact, in obese patients, the lung volumes that can be mobilized in the supine position are modified compared to the non-obese subject: decrease in vital capacity, decrease in expiratory reserve volume, increase in airway resistance, decrease in thoracic compliance. These changes are, in part, explained by the weight of tissue on the rib cage and abdomen leading to compression of the lungs and diaphragm. In addition, there is also an increase in oxygen consumption in patients with a BMI> 40. Different techniques have been proposed to increase apnea tolerance in obese patients. For Dixon et al., The desaturation of the morbidly obese subject (BMI> 40 kg / m2) is less rapid after 3 minutes of pre-oxygenation carried out with the patient in a half-seated position at 25 °: 201 seconds against 155 seconds in the Control group. This additional time seems to correlate with the value of the arterial pressure in O2 (PaO2) measured at the end of the pre-oxygenation (442 vs 360 mmHg). Likewise, the proclive position (30 ° reverse Trendelenburg) during the pre-oxygenation phase seems effective in limiting the occurrence of desaturation after induction. The O2 reserve is usually assessed by measuring the partial pressure of O2 in the arterial blood. A value greater than 100 mmHg indicates that an amount of O2 is "in reserve", increasing tolerance to apnea. In practice, this examination is not feasible in current practice because it requires the performance of an invasive procedure, cannot be measured continuously and the rendering of the result is delayed by several minutes. In recent years, a technology based on spectrophotometry has been developed to measure the saturation of Hb in O2 in non-pulsatile blood. By algorithmic transformation, an Oxygen Reserve Index (ORI) is calculated. Its value varies from 0 to 1 and covers a data range between 100 and 200 mmHg of blood pressure in O2 (moderate hyperoxia). This data is obtained continuously and non-invasively from a sensor (RD Rainbow SET R Sensors; Masimo) placed on the 3rd or 4th finger of the hand. When a patient receives an O2 enriched gas mixture, the value of ORI increases rapidly and reaches a plateau. When the patient is in apnea, the drop in the ORI value precedes the drop in SpO2 by several tens of seconds. In a pilot study observing the kinetics of ORI in non-obese (BMI <25 kg / m2) or obese (BMI> 30 kg / m2) anesthetized patients, we observed that the time required to reach the plateau of l The ORI was longer (133 ± 30 seconds) in "obese" patients compared to "non-obese" patients (89 ± 28 seconds). Thus, one hypothesis to explain the poorer tolerance to apnea in obese patients would be that the duration of 3 minutes of pre-oxygenation as recommended in the recommendations is insufficient.
This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.
The objective is to study the validity of the 6-minute stepper test (ST6) in order to determine tolerance to effort in cardiovascular patients
GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic
This is a randomized, double-blinded, 2 arms study concerning patients with high-grade bone sarcoma (HGBS) without complete remission after standard treatment at diagnosis or first relapse. In the first arm, patients will be treated with regorafenib + best supportive care (BSC) for a maximum of 12 months as maintenance therapy after standard line therapy completion, whereas in the second arm, patients will be treated with placebo + BSC (standard of care). The comparison between this two arms will allow to determine whether or not regorafenib and BSC is efficient for disease control, in terms of Progression-Free Survival improvement.
The purprose of this study is to develop and validate an analytical NIPD test for triplet repeat disesases by NGS analysis from maternal blood, searching for the familial mutation in families at risk of having one of the following triplet repeat diseases: Huntington's disease, Myotonic dystrophy, Fragile X syndrome.. A comparison of two 3rd generation long fragment DNA sequencing techniques will be performed. These methods are based of the phasing techniques of parental haplotypes without the proband.