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 purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies.
Many uncertainties remain regarding the epidemiological and clinical characteristics of COVID-19, including the number of people exposed to the disease, the persistence of the humoral response and its associated neutralisation capacity in recovered patients, and the long-term health consequences of the infection. The French national COVID-SeroPRIM survey aims to estimate the seroprevalence of IgG antibodies to SARS-CoV-2 in four populations of primary care health professionals: primary care physicians (general practitioners and paediatricians), health professionals working in city pharmacies (pharmacists and compounders) and in dental practices (dentists and dental assistants). Indeed, the majority of published studies target healthcare professionals in hospitals. It is therefore essential to provide new knowledge on the exposure of primary care workers to the virus in order to assess the impact of the pandemic, the level of immunity and the risk factors for exposure to the virus. These data will be very useful for public health decision makers to better adapt health protocols and provide useful information to better guide future vaccination campaigns. Assuming that vaccination against COVID-19 will start in January 2021, data on the vaccination rate of health professionals and their households will also be collected and made available to policy makers in a timely manner. This study will be conducted in collaboration with four primary care research and/or monitoring networks: the Sentinelles network (general practitioners), the Association de Formation Professionnelle en Pédiatrie (Association for Professional Training in Paediatrics), IQVIA (general practitioners and pharmacies), and the Réseau de Recherche Clinique en Odontologie Libérale (ReCOL, dental surgeons) Seroprevalence will be estimated using a high-sensitivity ELISA designed to detect SARS-CoV-2 specific IgG antibodies in humoral fluid and a high-specificity seroneutralisation test to assess seropositivity (i.e. excluding false positive ELISA results due to cross-reactivity with other coronaviruses) and to assess SARS-CoV-2 neutralising antibody levels. These techniques have already been used in two general population cohort studies (SAPRIS-SERO and EpiCoV) with the objective of describing SARS-CoV-2 seroprevalence and risk factors. The secondary objectives of the COVID-SeroPRIM study will be to assess the seroprevalence of IgG antibodies to SARS-CoV-2 in household contacts of health care workers, to identify risk factors for seropositivity to SARS-CoV-2, and to retrospectively describe the symptoms experienced by individuals diagnosed with COVID-19. Due to the use of the same methodology to assess seroprevalence, these results will be broadly complementary and comparable to those of seroepidemiological studies conducted in the general population, such as EpiCOV and SAPRIS-SERO. These surveys (EpiCOV, SAPRIS-SERO and COVID-SeroPRIM) as a whole are based on similar questionnaires and identical serological methods and will provide many health indicators such as the proportion of people who presented symptoms, who consulted for a suspicion of COVID-19, who were screened but also who did not seek care in the recent period. The COVID-SeroPRIM study, by targeting primary care health professionals and their households, will provide data to reinforce the knowledge from SAPRIS-SERO and EpiCOV and to better understand the dynamics of the epidemic in these four populations in order to guide public policy makers. This project has received funding from the French National Research Agency (ANR) as part of the COVID-19 call for research projects, which aims to support urgent and rapid projects whose results could be implemented in society in the coming months. Main objective To estimate the seroprevalence of IgG antibodies to SARS-CoV-2 in four distinct populations of primary care health professionals (general practitioners, paediatricians, health professionals practising in city pharmacies and dental practices) in metropolitan France.
Coronavirus disease 2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), may predispose patients to thrombotic disease due to a state of profound inflammation, platelet activation, and endothelial dysfunction leading to respiratory distress and increased mortality. The incidence of macrovascular thrombotic events varies from 10 to 30% in COVID-19 hospitalized patients depending on the type of arterial or vein thrombosis captured and severity of illness . Observational results in patients receiving routine low-dose prophylactic anticoagulation (LD-PA), several institutions have recently released guidance statement to prevent macrovascular thrombotic events with dose escalation anticoagulation. In these recommendations, high-dose prophylactic anticoagulation (HD-PA) and therapeutic anticoagulation (TA) can be employed either empirically or based on the body mass index and increased D-dimer values. No randomized trial has validated this approach, and other recent recommendations challenge this approach. Microvascular thrombotic events are also of major concern in critically ill patients with COVID-19, even in the absence of obvious macrovascular thrombotic events. A large review of autopsy findings in COVID-19-related deaths reported micro thrombi in small pulmonary vessels. More generally, COVID-19-induced endothelitis and coagulopathy across vascular beds of different organs lead to widespread microvascular thrombosis with microangiopathy and occlusion of capillaries. Thus, in severe COVID-19 patients requiring oxygen therapy without initial macrovascular thrombotic event, a HD-PA or a TA could be beneficial by limiting the extension of microvascular thrombosis and the evolution of the lung and multi-organ microcirculatory dysfunction. In a large observational cohort of 2,773 COVID-19 patients, a lower in-hospital mortality in ventilated patients receiving TA as compared to those receiving PA (29.1% vs. 62.7%). Our hypothesis is dual: i) first, that TA and HD-PA strategies mitigate microthrombosis and each limit the progression of COVID-19, including respiratory failure and multi-organ dysfunction, with in fine a decreased mortality and duration of disease, as compared to a low-dose PA; ii) second, that TA outperforms HD-PA in this setting.
Recent EMA and FDA approvals have made immune checkpoint inhibitors (ICI) a standard of care in cancer treatment. ICI, used alone or as a combination are now the backbone of renal cell and lung carcinoma treatment. However, a significant proportion of patients does not respond to ICI. Thus the identification of predictive response factor is a major issue. While factors associated with the tumour and its micro environment have been widely studied, factors associated with the patient such as metabolism could also affect the response to ICI and remain poorly studied. The hypothesis of the investigators is that dysmetabolims, via the induction of a chronic inflammatory state could induce a defect of lymphocyte production and activation as well as a modification of the immunogenicity of tumor cells and immune cells infiltration. The consequences could be a decrease in ICI response rate as well as an increase in immune related adverse events (irAEs). To test this hypothesis, the investigators propose a prospective bi-centric exploratory study including 60 patients treated with ICI for advanced lung or renal cell carcinoma. The data collected will be : - Clinical (calorimetry, impedancemetry, survey of eating habits, tumour characteristics, epidemiological data), - Biologics (baseline and 3-months plasma bio banking for standard biology, inflammation markers TNF- α, IL1-6-8-11-17, TGF-ß, TWEAK, complement study C3, C4, C4d, CH50, C1q, CD46) Primary objective is to assess the response to ICI depending on metabolic status. Secondary objectives are to study the relationships between metabolism / cytokines profile/ complement profile and ICI response. The investigators seek to generate hypotheses and to obtain exploratory data before submission of a Hospital Clinical Research Program whose objective will be to evaluate the impact of dysmetabolism on overall survival and to characterize immune and anatomopathological profiles (using DNA microarrays and flow cytometry techinques) of patients treated with ICI for renal cell or lung carcinoma.
Cancer survival rates have improved significantly over the past decades and patients now experience a number of side effects including cancer-related cognitive impairment (CRCI): problems with memory, executive function, attention, and difficulties performing two tasks at the same time. The frequency of CRCI in cancer patients is estimated to be between 10 to 40%, and more than 50% of patients describe difficulties in their daily life. These cognitive difficulties negatively impact the patient's quality of life as well as that of their family, and can also have negative consequences for their social and professional reintegration once cancer treatment is finished. Despite an increasing number of studies on CRCI, a standard of care for patients with CRCI after breast cancer is yet to be established. In the absence of clear directives, and in an attempt to respond to the increasing demand to provide care for breast cancer patients with CRCI, physical medicine and rehabilitation units in France have started providing day-hospital multidisciplinary interventions. The objective of this project is to use the single case experimental design method to investigate the efficacy of two such rehabilitation programs: a group-based program and a one-on-one program.
This is a Phase 3, open-label, multicenter study to evaluate the safety, efficacy, PK, PD, and immunogenicity of cipaglucosidase alfa/miglustat treatment in ERT-experienced and ERT-naïve pediatric subjects with IOPD.
The purpose of this study is to evaluate intubation conditions with the use of atracurium after a fixed three-minute delay
the aim of the SERAPHINE study is to gather data stemming from the French research database BERHLINGO (= Base d'Etude et de Recherche en Hémostase pour Les Investigateurs du Grand-Ouest, i.e. Database for Research on Hemostasis for the Investigators of Western France), in order to get a detailed report about the therapeutic management and use of turoctocog alfa (NovoEight®) in surgery in pwHA (Patient with inherited Hemophilia A).
Evaluation of the physiological and clinical effects of the biofeedback training with patients suffering from somatoform disorders, depending on their neurovegetative profile related to a visceral-brain decoupling.
Multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trial to assess the antitumor activity of berzosertib in association with gemcitabine