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.
In 2014, the french hospital emphasized the need for tools to screen for social fragility in order to make explicit the choices of orientation of patients. To date, caregivers do not have any tools or clinical benchmarks for individual assessment of pediatric social and health vulnerability. The use of the Health Care Access Permanence Services (PASS) is intended to facilitate access to the health care system for people in precarious situations with care and social support within and outside the institutions. health. The hypothesis tested is that the use of a formalized tool makes it possible to improve the detection of pediatric social vulnerability and to overcome reluctance to practice by a simple, rapid and justified approach with regard to ongoing care. The primary objective is to validate a clinical tool for screening for pediatric social and health vulnerability - Tool: VUlnerable Child (ENVU) -; to allow for an appropriate orientation of the patient care pathway. The metrological validation of diagnostic performances (sensitivity, specificity, positive and negative likelihood ratios) will be studied in confrontation with the opinion of an expert caregiver in the care of vulnerable populations. This multicenter cross-sectional validation study of the screening tool will be conducted in two SAUPs with a pediatric PASS. 1000 children will be included in the centers for a period of 1 year. Following the introduction of the ENVU tool and after an expert interview, three groups of patients will be identified: Group A: no vulnerability according to expert with no indication of any PASS marker care Group B: probable vulnerability according to the expert with indication of at least one PASS marker care Group C: high vulnerability according to the expert with indication of at least two care markers PASS Group B and C patients will be reviewed at 6 months for a second visit to the ENVU tool. The main evaluation criterion will be the concordance between the indication of the use of the PASS by the "expert" PASS nurse (indicator of a significant social and health vulnerability) and the result of the ENVU tool.
Infant lead poisoning is the clinical expression of lead poisoning. This environmental disease, still present in France, is the only notifiable non-infectious disease. Its complications include, in the foreground, disorders of psychomotor development but also include in adults the attack of other systems. The fight against lead poisoning mainly involves the removal of lead sources. Several methods of eviction exist: a modification of the practices, a palliative rehabilitation, a definitive rehabilitation and a relocation. The effectiveness of each method is not documented. This study therefore aims to compare the effectiveness of these various measures to eliminate the risk of exposure to lead on blood lead. This study uses the methodology of a multicenter historical cohort. It will begin in the second quarter of 2017. The research centers will be child-environment consultations and mother-child PASS in Avignon, Manosque, Marseille, Nice and Toulon. The study will be offered to all children monitored in these centers since 2011. The inclusion criteria will include: age <18 years, at least one blood lead ≥ 50μg.L-1, residence declared in PACA and absence opposition. The retrospective data will be incorporated into the prospective monitoring. The necessary number is at least 165 cases of infantile lead poisoning (of which 33 per type of intervention). The primary endpoint will be the kinetics of quarterly venous blood lead. The smallest clinically significant difference in blood lead levels will be 50μg.L-1 between the different groups. Statistical analysis will use intra- and inter-individual variability analysis by compartmental modeling of the pharmacokinetics of blood lead. An interim analysis will be conducted in 2017 on the retrospective data to confirm the necessary staffing.
Neutrophil cytoplasmic autoantibodies (ANCA) are essential serum markers in the diagnosis of vasculitis. Indirect immunofluorescence with microscope reading by two readers is the reference technique for their detection. In the AP-HM immunology laboratory we are looking for ANCAs in more than 7000 sera per year. The reading of the slides is time-consuming, dependent operator, and lacks standardization. In order to optimize these parameters, we propose the automation of ANCA reading by using a robotic platform developed in our laboratory and called ICARE (Immunofluorescence for Computed Antibodies Rational Evaluation). This microscopic imaging platform with automated reading is currently used in daily routine for the detection of anti-nuclear autoantibodies. The objective of the project is to establish an algorithm allowing i) to automatically and reproducibly discriminate the positive ANCAs from the negative ANCAs and ii) to propose to the biologist a fluorescence aspect. The investigators will then validate this algorithm on 2000 consecutive routine samples sent to the laboratory for ANCA research. The usual care will not be changed, only a phase of acquisition of the images will be added to the analysis. The investigators expect to use this algorithm "ICARE / ANCA" in daily hospital routine and thus optimize the results with a real economic impact is 50% less reading time.
Despite sustained inhibition of viral replication in plasma undergoing treatment, nearly 30% of HIV-infected patients have HIV-related cognitive impairment. To date, no therapeutic strategy has demonstrated clinical efficacy. The initial hypothesis is to use the non-medical techniques of cognitive remediation commonly practiced in the treatment of Alzheimer's disease to allow improvement or even regression of cognitive disorders in HIV-infected people (PHAs) who are virologically tested on antiretroviral combination therapy (ART). Some recent pilot studies using individual computer-based cognitive remediation strategies show improved test performance. However, none have studied the impact of this strategy on PPHIV with cognitive impairment. A single-center pilot study evaluating the efficacy of an individual cognitive remediation program for 6 months on the improvement of cognitive impairment in patients with stable plasma HIV viral load that is undetectable under stable antiretroviral combination (cART) cognitive disorders related to HIV infection. The primary objective is to demonstrate improvement through a 6-month individual cognitive remediation program on cognitive impairment (1 standard deviation variations on 2 M6 neuropsychological tests) in controlled HIV-positive individuals under cART with cognitive disorders related to HIV. Methodology: Monocentric, prospective, pilot study of 40 patients performed in an open period of 25 months. The inclusion period is 13 months and the participation duration per patient is 12 months. After an inclusion visit, patients start 15 days of individual cognitive remediation sessions. The cognitive remediation will be led by a psychologist specialized in neuropsychology, trained and experienced in this method. Cognitive remediation will be performed at a rate of 1 to 2 sessions per week. Each patient will be assessed initially (M0) at 6 months (M6) and 12 months (M12: 6 months after stopping cognitive remediation) with a battery of standardized neuropsychological (NP) tests performed by a neuropsychologist. Primary endpoint: Improved cognitive impairment after 6 months of cognitive remediation, with each patient being their own control, defined by improvement on at least 2 tests of 1 standard deviation minimum.
Follicular thyroid cancers are excellent prognoses. However, there is a very clear negative impact of the diagnosis on patients' quality of life, partly because of initial care. The therapeutic sequence is often the following: surgery and complementary administration of radioactive iodine 131. This treatment will destroy all thyroid cells remaining and thus minimize the risk of recurrence and facilitate future controls. Radioactive iodine uptake is optimized by stimulating thyroid cells that fix iodine better when the level of TSH is high. For this purpose, hypothyroidism is induced by weaning in hormone replacement therapy or injected with recombinant TSH. Then, a full-body scintigraphy extension is performed followed by a medical consultation. This scintigraphy shows the tissues that fixed the iodine 131, the residual tissues after surgery and / or possible distant metastases. It is recognized that when a patient learns that he has thyroid cancer, he is subject to increasing anxiety between the time of diagnosis and post-treatment scintigraphy. These patients and their loved ones are often distraught and anticipate their future in a negative way, while long-term survival is excellent. How to get these patients to consider their pathology more objectively and thus reduce their anxiety? Sophrology is a psychocorporal method aimed at balancing our emotions, thoughts and behaviors. We suppose that if these patients could benefit from a sophrological accompaniment between the announcement of the diagnosis and the scintigraphy, they could apprehend their pathology with more serenity and reality. No studies providing sophrological support to patients with thyroid cancer have been performed. The anxiety of these patients being largely linked to a feeling of isolation and excessive danger, we think that this care will have an immediate favorable effect on their anxiety, or even in the longer term on their quality of life. The aim is to offer patients a sophrological support provided by each of the 3 participating centers. These group sessions will allow them to understand the place of their future hospitalization, to share with other patients, to obtain answers to their questions, to be listened to with neutrality and empathy, and to learn management techniques. their anxiety in order to reproduce them at home. They will be followed and will not feel abandoned in the face of their distress.
Medullary thyroid carcinoma (MTC) develops at the expense of calcitonin cells and is often characterized by lymph node metastases and sometimes visceral metastases. Improvement of preoperative diagnosis is of major importance in CMT because the quality of the initial surgery determines the prognosis. In recent years, 18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET / CT was considered the most sensitive functional imaging tool in the evaluation of persistent CMT. To date, 18F-FDOPA PET at initial diagnosis has been reported in a few clinical cases. The main objective is to demonstrate that 18F-FDOPA PET provides additional information compared to conventional imaging on the initial diagnosis of CMT patients. The secondary objectives are to describe the nature of the information provided by PET / CT imaging, the main factors influencing tracer uptake and the positivity of PET / CT, and the impact of the examination on the care of the patient. This is a prospective, multicenter and open study. Patients with TCM who have serum calcitonin> 150 pg / ml at initial diagnosis and have performed baseline imaging examinations within the last 3 months will be included in the study . A PET at 18F-FDOPA will be performed according to a very powerful acquisition protocol. Image analysis will be performed blindly from the results of conventional imaging. All exams will be compared, in accordance with the gold standard. Therapeutic intentions will be collected before and after the PET imaging, as well as the actual management in place.
The smoke produced by the electric section of the tissues during laparoscopy alters the vision of the operative field and presents potential risks. A new medical device with CE marking (Ultravision ©) has been developed to limit electroprecipitation on the wall and tissues of the abdomen. The aim of the work is to evaluate the effectiveness of this medical device in laparoscopic cholecystectomy for cholecystitis. It is an intervention for a common pathology where smoke is particularly important due to the tissue inflammation and due to the extensive dissection necessary to perform the surgical procedure. A randomized double-blinded study will be conducted in two academic hospitals (Marseille North Hospital and Timone, APHM) evaluating the use of a smoke electroprecipitation device (Ultravision ©) during laparoscopic cholecystectomy for cholecystitis operated at the acute phase. A group of 30 patients using the device will be compared to a control group of 30 patients. The evaluation will last thirty days per patient and the duration of inclusion is 2 years. The main objective is to demonstrate a significant reduction in operating duration by using the device. The secondary objectives are to reduce the CO2 consumption, the surgical incidents and the discomfort of the surgeon related to the smoke.
Pyoderma gangrenosum (PG) is a rare disease. She is often under diagnosed and a source of diagnostic wandering and inadequate care. Moreover, its association in more than one case out of two to a significant underlying pathology, such as inflammatory bowel disease, inflammatory rheumatism, or hematology, makes its diagnosis essential. Its pathophysiological mechanisms remain controversial and many other comorbidities have been reported in the literature, including endocrinological, cardiovascular and metabolic, neoplastic and autoimmune comorbidities. The objective is to study the field, comorbidities and pathologies associated with PG on a series of patients diagnosed with PG, as well as to characterize the clinical and histological aspects of lesions. A retrospective observational non-interventional multicenter study is proposed. 10 French centers. The recruitment will be done via the DIM using coding software: codes L984 , L982 and L97 according to 2 major criteria (typical clinical appearance with ulceration well limited and purulent or pustule hutches, exclusion of differential diagnoses) and at least 2 minor criteria (among compatible histological aspect, classically compatible associated pathologies, corticosensitivity of lesions, pathergie phenomenon, painful lesions). Demographic data, clinical appearance of the lesions, cardiovascular and metabolic comorbidities, other associated pathologies, histological findings of the ulcer biopsy and biological results to describe the population and associated pathologies or comorbidities to PG
Consensual antibiotic protocols have been developed and validated locally by infectious disease specialists, internists and emergency physicians, in order to encourage their compliance. A preliminary study was conducted from June 2015 to February 2016, including 622 patients admitted to the emergency department for infectious syndrome such as / - Pneumoniae - Urinary tract infection - Cellulitis - Meningitis - Malaria - Febrile neutropenia - Febrile acute diarrhea - Fever back to the tropics - Angina - sexually transmitted infection This prospective study will observe and analyze the adherence of prescribers to these protocols. With description of patients who benefited or not the antibiotic protocol, according to a syndromic approach and analysis of the causes of non-adherence to the protocols. In order to limit the length of stay and reduce the cost of hospitalization..
Despite surgery and first-line standard of care which consist of radiotherapy with concomitant and adjuvant temozolomide, all patients with glioblastoma (GB) will experience relapse. At the time of recurrence, therapeutic options include surgery or reirradiation in selected cases, while in other cases, bevacizumab, approved by Food and Drug Administration (FDA) but not European Medicines Agency (EMA), is the preferred option worldwide. Primary and acquired resistance to bevacizumab has been explored without definitive finding. Biomarkers able to predict response to antiangiogenic agents and particularly to bevacizumab are an unmet medical need. We have showed that a low Matrix metallopeptidase 9 (MMP9) or a high Matrix metallopeptidase 2 (MMP2) baseline plasma levels were associated with a high response rate and a prolonged Progression-free survival (PFS) and overall survival (OS) in recurrent GB patients treated with bevacizumab but not with cytotoxic chemotherapy. We also observed that MMP9 plasma level decreased during bevacizumab treatment and tend to increase at progression. Finally, in a retrospective analysis performed in the Avaglio trial (a randomized phase III trial that tested bevacizumab versus placebo in addition to standard of care in patients with newly diagnosed glioblastoma), a low plasma level of MMP9 at baseline predicted consistently PFS and OS gain associated to bevacizumab. These results are consistent with the role of MMP9 in vasculogenesis, since MMP9 contribute to the recruitment of circulating endothelial and myeloid precursors, an alternative vascularization process which is in part independent of the vascular endothelial growth factor (VEGF) pathway. Monoclonal Antibody (GS) 5745 is specifically directed against MMP9. First in human phase I study has been completed. Development is ongoing. Our results strongly support a role for MMP9 in the primary or acquired resistance to bevacizumab. Therefore, we hypothesize that the Monoclonal Antibody GS5745 may overcome resistance to bevacizumab through a specific inhibition of MMP9. While a preclinical program is initiated in our lab, the proposed phase I study is the first step to analyze the tolerance, determine the recommended dose of the combination and explore the impact of GS5745 on MMP9 plasma levels and multimodal imaging in patients with recurrent glioblastoma. Objective: Determine the safety profile and tolerability of GS5745 given in combination with a fixed dose of bevacizumab in patients with recurrent GB in terms of Dose-Limiting Toxicities. Multicenter, open label, dose-finding study of GS5745 in combination with bevacizumab administered at a fixed dose; both drugs will be administered once every two weeks for a total treatment duration of a maximum of 12 months. Before initiation of each new dose level, a meeting between the sponsor, the coordinator, the investigators and an independent external expert will take place to decide jointly the next dose.