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 pilot study is to assess the safety and tolerability of multiple doses of MaaT033 in ALS patients and to analyze the gut microbiota composition and evolution before considering a larger randomized controlled efficacy study.
Patient autonomy is recognized throughout the world, by caregivers, as a value. The idea of autonomy has been the keystone of the changes accomplished in the contemporary history of health law. It is about respect for everyone to have their own health and to choose the options that correspond to their wishes, their values or their life projects. The recently revised definition of pain specifies that it is "an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage". In this, pain is always a personal experience that is influenced to varying degrees by biological, psychological and social factors. The High Authority of Health considers pain as chronic is considered when it is persistent or recurrent beyond what is usual for its presumed initial cause (most often beyond 3 months), that it responds harm to treatment and that they induce a significant and progressive deterioration of functional and relational capacities. Chronic pain confines patients on a psychosocial level. It is no longer just a symptom, it is even a disease in its own right since 2019 with the new classification of diseases proposed by the World Health Organization.In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state". In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state".In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state". In current practice, this skill is assessed in case of doubt (generally when there is uncertainty about the patient's understanding of the issues and his involvement in the therapeutic project) intuitively, by following a Socratic questioning or from grids like the MacCAT-T. In the pain center, investigators use the MacCAT-T but investigators have not yet systematically measured the benefit and the cost of using this questionnaire in everyday practice. In particular, investigators want to know if the skill is not overestimated by the doctor in charge of the patient.
Isatuximab was developed on a sub-cutaneous (SC) administration format. SC administration is expected to be more convenient for the patient, with a much shorter duration of administration compared to the currently approved IV route. The SC Isatuximab RP2D fixed dose was determined at 1400 mg in a phase1b assessing SC Isatuximab in combination with pomalidomide and dexamethasone in RRMM patients. A similar activity and a favorable safety administration profile compared to the IV formulation, was shown in this trial, as expected (Moreau et al, ASH 2021; Quach et al, ASCO 2022). This data should be confirmed in the ongoing IRAKLIA/EFC15951 phase 3 study, that compared in the RRMM, isatuximab plus pomalidomide and dexamethasone IV versus SC. Whether isatuximab SC, fixed 1400 mg dose, will show similar efficacy and safety profile as to anti-CD38Rd+V remains to be demonstrated. The investigators have planned to study the combination of SC isatuximab plus VRd (IsVRd) in patients with NDMM NTE in a phase 2 study across IFM (Intergroupe Francophone du Myeloma) centers in France to compare indirectly this data to the data obtained from studies that have studied this association in that population with the IV isatuximab formulation.
Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This study will assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of HS. This study is "double-blinded", meaning that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo. This study is comprised of 3 periods. In Period 1, participants are randomized into 2 groups called treatment arms where each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In Period 2, participants are placed into 6 different groups depending on their placement and results in Period 1. Period 3 is the long-term extension period where participants will continue treatment from Period 2. Approximately 1328 adult and adolescent participants diagnosed with HS will be enrolled in approximately 275 sites worldwide. Participants will receive oral tablets of upadacitinib or placebo once daily for 36 weeks in Period 1 and Period 2. Eligible participants from Period 1 and Period 2 will enter Period 3 and receive oral tablets of upadacitinib or placebo once daily for 68 weeks. Participants will be followed up for approximately 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Microbial keratitis is a severe and often blindness-inducing pathology which represents today the first reason for long-term hospitalization (more than 5 days) in ophthalmology. Its diagnosis is clinical and leads to an immediate hospitalization in the presence of serious criteria (Mackie classification). The entire process of microbiological diagnosis requires several days before etiological confirmation and therefore delays the initiation of targeted therapy. Recently, new PCR systems allowing the detection of 18 to 27 pathogens in 75 minutes have been developed. Their use could thus be transposed to ophthalmology by adapting the microbiological diagnostic technique to samples currently taken by swabbing the cornea. The investigators will compare their diagnosis performance versus conventional methods on patients who suffered for a microbial keratitis with severity criteria.
Assessing the response to vascular filling in shock is a challenge in emergency medicine. The mitral annulus velocity measured by tissue Doppler (E') has recently been characterized as sensitive to the preload conditions of a patient. The investigators hypothesize that the E' variation (∆E') before and after fluid filling allows us to assess the response to vascular filling. The investigators hypothesize that the ∆E' has a good diagnostic performance to establish whether a patient is responsive to fluid filling, defined by an area under the ROC curve greater than 0.75.
The aim of the MAPEG 2 study is to explore gustatory function and to follow its evolution in the 5 following groups of participants: - Healthy subjects - Participants with isolated cognitive complaint - Participants with minor neurocognitive disorder - Participants with mild Alzheimer-type major neurocognitive disorders - Participants with moderate Alzheimer-type major neurocognitive disorders For this purpose, we want to compare the results of the following tests: - Subjective taste tests (tasting solutions, answering food preference questionnaires), - Gustatory evoked potential (GEP) parameters, recorded by electrodes placed on the scalp, - And nutritional parameters (hormones of food intake by blood test, measurement of the global body composition). Identifying and following the evolution of early taste disorders in case of cognitive disorders could improve the diagnosis of Alzheimer's disease in two ways: - To allow an early diagnosis of Alzheimer's disease, and thus improve its management, - To define groups of subjects at risk of developing Alzheimer's disease in later years.
Reducing surgical waiting time has been shown to be associated with a reduction in postoperative morbidity and mortality in this type of surgery. The use of a gradation of surgical emergencies makes it possible to prioritise them in an objective, consensual manner and to carry them out within a theoretical expected waiting time relative to the degree of urgency. The investigators hypothesise that exceeding the theoretical expected waiting time relative to the degree of urgency defined by the gradation of surgical emergencies is associated with an increase in postoperative morbidity and mortality in emergency surgery. The objective is to assess the impact on post-operative morbidity and mortality of waiting times exceeding the theoretical expected time by grading the surgical emergencies of patients undergoing emergency surgery.
Dental periapical damages can have various reasons and is reflected by a radiolucent lesion on complementary imaging: angulated retro-alveolar (RA) radiographs, dental panoramic radiographs, and three-dimensional imaging such as computed tomography (CT) or cone-beam computed tomography (CBCT). For the radiographic detection of these deep periodontal lesions, the dental panoramic represents a first approach commonly performed with relatively low radiation. The investigation can be followed by retroalveolar radiology imaging that are more localized and more precise. However, using these techniques, the detection rates of these lesions are low (20% and 36% respectively), it is necessary to use three-dimensional tomographic investigation to be more discriminating (69%). The gold standard imaging for detection of these lesions is CBCT followed by retroalveolar radiography (~2x less sensitive than CBCT) and panoramic radiography (~2x less sensitive than RA). Although not a full-thickness radiograph, the dental panoramic has the advantage of being more commonly performed while being less radiating than CBCT and giving a global view of the dental arches on a single image. The detection of periapical lesions is done after a clinical assessment and a visual appreciation of the complementary examinations. The aim of this project is to improve the detection of periapical lesions, by developing an algorithm able to identify them on a panoramic dental radiograph. This algorithm is based on a deep learning system trained with reference data including panoramic dental imaging and CBCT with an acquisition interval of less than 3 months. The model is based on a previous work, will improve the quality of the initial data (using CBCT), using innovative artificial intelligence algorithms (transfer learning).
Multicentric, prospective, multi-indication, single-treatment arm, open-label phase II trial assessing the efficacy of MEDI5752