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.
Based on the evidence that periostin is specifically involved in intra-cortical remodeling control, our working hypothesis is that assessment of its concentration in the serum would be helpful in identifying patients with severe cortical porosity, a critical parameter in bone fragility. Periostin expression by osteoblasts and osteocytes is part of the bone cortical response to anabolic stimuli such as mechanical strain or intermittent increase in parathyroid hormone. However, it remains unknown whether this expression may participate as well to mechanisms that will lead to exaggerated intra-cortical remodeling and subsequent bone loss. In rare clinical situations in which trans-iliac bone biopsies will be necessary to better understand their bone status in addition to densitometry and biological bone markers assessment, specific analyses using immune-staining techniques will be performed on the bone sample. Data from routine follow-up every six months will be also collected in this specific sub-group. High resolution peripheral quantitative computerized tomography (HR-pQCT) gives the opportunity of performing a virtual bone biopsy providing information on trabecular and cortical microarchitecture in vivo. These microarchitectural parameters allow a more accurate evaluation of the alteration of the bone structure and therefore of the fracture risk as compared to current tools used in clinical practice such as densitometry. However, the availability of such HRpQCT facilities is limited and there is on-going development on the best way of measuring porosity for example. The definition of a biological profile including key proteins such as periostin and sclerostin involved in porosity mechanisms is therefore of great interest. A better understanding of the relationship between bone matrix components and parathyroid hormone effects also appears as critical. Follow-up of routine evaluation parameters reflecting bone status in a subgroup of specific patients could also provide new and additional information.
The purpose of the study is to evaluate the performances of Soluble Fibrin assay for exclusion of Pulmonary Embolism and Deep Venous Thrombosis. Secondary objectives are to determine the threshold value from the ROC curves, the possible interest in the positive diagnosis of Venous Thromboembolism (VTE), and to verify the absence of influence of age on the SF results.
To investigate exposure to nonsteroidal antiinflammatory drugs (NSAIDs) during outpatient management at the early stage of community-acquired pneumonia (CAP) requiring hospital consultation. Non-interventional observational study.
Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic increase of red blood cells and frequently also of white blood cells. The "thickening" of the blood in relation with a modified function of the cells has several consequences like increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the brain as well as fingers and toes and an increased risk of arterial and venous thrombosis (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction, deep vein thrombosis in the legs. In case of a strong increase of platelets there is an additional risk of bleedings. As the disease progresses the size of spleen and liver increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a progression at a later time point to a leukemia (increased formation of white blood cells) can occur. The aim of this study is to assess the ease of AOP2014 self-administration using dedicated questionnaires. - To assess safety and tolerability: adverse events (AEs), laboratory parameters, electrocardiogram (ECG) throughout study. - To assess maintenance of the blood efficacy parameters Hct (Hematocrit), WBC (white blood cells) and PLTs (platelets) and spleen size (comparing values at Visit P7 vs. values at Visit P1). - To assess the feasibility of AOP2014 self-administration: defined as the ability of the patients to use the pen as a self-administration tool (ease of handling, safety, tolerability and efficacy).
Routine screening mammography has increased the non-palpable suspicious lesion detection rate, requiring histopathological evaluation. The discovery of atypical lesions on the breast biopsy is associated with two interrelated risks: 1. The risk of underestimating the severity of the lesion biopsied currently leads systematically to achieve a surgical resection for these patients while a breast cancer (BC) will finally identified at surgery in 10 to 25% of cases. Thus, unnecessary surgeries will be performed in 75 to 90% of cases (no cancer). 2. These breast lesions confer long-term increase in the subsequent risk of breast cancer (cumulative incidence of 15 to 25% at 25 years). Thus, women identified with atypical lesions are then followed using clinical and mammographic annual evaluation. The goal would be to get a model to assess the risk and no longer operate those patients at high risk of BC. Several groups have attempted to identify predictors of concurrent or secondary BC associated with the discovery of an unusual lesion at biopsy. However, they are often focused on a subtype of atypia (eg atypical metaplasia, atypical ductal hyperplasia, atypical lobular hyperplasia) and no prediction model has been validated in prospective multicenter. Based on a large retrospective study at Gustave Roussy, a prediction model (Nomat) has been developed, common to all atypical lesions, which can predict the presence of a BC at excision surgery (risk of concurrent BC). This model is based on the age of the patient, the disappearance of radiographic abnormalities (microcalcifications in general) after the biopsy and initial radiological lesion size. This model has good performance with an area under the curve (AUC) of 0.72. In previous series, with a BC high-risk threshold of 20%, negative predictive value was 90%, and this model would have prevented the surgery in 51% of patients (low risk patients by model). It is essential to validate this model by forward-looking and in different centers to ensure its relevance. This is a multicenter prospective validation of the model on 300 patients operated for atypical lesions in 21 centers. All patients with atypical breast lesions have a routine surgery. The clinical data, imaging and histological data will be collected prospectively. The main objective of this study is to validate the model Nomat.
Bronchoscopy with bronchoalveolar lavage (BAL) is at risk for worsening hypoxemia in patients with acute respiratory failure (ARF). High-flow nasal cannula oxygen (HFNC) improves hypoxemia in ARF patients . We investigated its efficacy and tolerance in intensive care unit patients admitted for ARF requiring BAL.
Mechanical thrombectomy (TM) is now validated through 4 randomized controlled trials of high scientific level as the reference treatment of cerebral infarction associated with proximal cerebral occlusion (MR CLEAN, ESCAPE 2014, 2015). These studies have shown for the first time a major decrease (-35%) of disability related to severe cerebral infarction and reduction in mortality. These studies only used thrombectomy devices called stent retriever for obtaining recanalization rates ranging from 58-72% for the 2 largest studies (MR CLEAN, ESCAPE 2014, 2015). This criterion "recanalization" is important because it largely determines the functional prognosis of patients with severe cerebral infarction (Khatri, 2014). These results are exciting but we can do even better. Indeed, already new thrombectomy devices are available with a special interest for ADAPT (A Direct Aspiration First Pass Technic). This distal suction system, with a high level of endovascular navigability, provides high recanalization rates (> 90%), low morbidity, with a synergistic effect with stent retriever (Turk A, Kowoll 2014 and 2015). To date, these technic (ADAPT) has never been assessed in a randomized controlled trial. We have previously conducted a comparative observational study between two recanalization strategies by thrombectomy using first-line ADAPT or the most widely used stent retriever. The interventional neuroradiologist could, in case of recanalization failure with the Solitaire system, used another thrombectomy material left to the operator's choice. 244 consecutive patients on two centers (Rothschild Foundation, and Foch Hospital, France) admitted for a cerebral infarction associated with proximal occlusion were included. This is so far the largest series of patients with ADAPT system. The complete recanalization rate was 84% with ADAPT versus 68% with stent retriever (P = 0.006). Unpublished data, Oral presentation at the European Stroke Organization, April 2015). Our research aims to show that a first line strategy of recanalization by thrombectomy using a distal suction system (ADAPT) is superior that the use of a stent retriever.
While the duration of renal transplant function has increased over the last decade kidney transplanted patients (KTP) still exhibit a fracture risk 4 times higher than in the general population. Fracture risk remains increased despite the improvement of immunosuppressive therapies (IST) that allowed the reduction of steroid administration. Potential explanations for this could be 1) that Chronic Kidney Disease (CKD) induces renal osteodystrophy that occurs before kidney transplanted, impairs bone metabolism and promotes bone fragility ; 2) that kidney transplanted patients are older and older (14% of kidney transplanted patients were older than 70 in 2011 in France), ageing being a major risk factor for fractures 3) IST, besides steroid, may have deleterious effects on bone and 4) that secondary hyperparathyroidism, a risk factor of fractures, persists after kidney transplanted . Thus, the pathophysiology and epidemiology of bone fragility of kidney transplanted patient remains insufficiently characterized. Despite these data, and contrarily to what is done for patients candidates for cardiac transplantation, there is no general consensus for performing bone evaluation before kidney transplanted . Thus it's necessary to individualize the management of bone fragility and prevent fractures according to strategies that remain to be defined, provided that patients at risk are better detected.
This project is focused on the treatment of obstructive sleep apnea in the acute phase of stroke. Stroke is a frequent pathology with a high morbidity and mortality rate. Although it has now been proved that obstructive sleep apnea syndrome (OSAS) is a risk factor of stroke, on the other hand, there is evidence that 50 to 70% of patients in the acute phase of stroke have obstructive sleep apnea (OSA) based on an apnea-hypopnea index (AHI) of ≥ 10. OSA is associated with worse functional outcomes and higher mortality in the post-stroke period. Profound hemodynamic fluctuations and hypoxia generated by sleep apnea are likely to aggravate cerebral ischemia, particularly in the acute phase of stroke in the potentially reversible ischemic penumbra. Continuous Positive Airway Pressure (CPAP) is the primary treatment for obstructive sleep apnea. Yet, to our knowledge, there have been very few studies aimed at demonstrating the value of CPAP in the treatment of obstructive sleep apnea in the acute phase of stroke. Only one randomised trial has provided the means to document neurological improvement at mid term (1 month) in a targeted population. Before undertaking a comparative study evaluating the efficacy of CPAP in the acute phase of ischemic stroke, it is worth evaluating the feasibility and tolerance of introducing CPAP at the very early stage of ischemic stroke. Therefore, the purpose of our study is to evaluate the feasibility of CPAP in the treatment of OSA in the acute phase of ischemic stroke.
In spite of all progress realized in the field of assisted reproduction the pregnancy rate by In vitro fertilization (IVF) in France, across indications, is only 23% after IVF cycle. Different causes may account for these failures and that, during all stages of pregnancy. Recent studies have investigated an essential step in fecundation : uterine receptivity. Some teams have shown that a lot of immunological factors would have very significant in this step, by them possible expression in this process. Other studies looked at genes modulation, essential to implantation, with endometrium manipulation, simple, such as endometrial biopsy (EB). The last findings published on this subject, but after 2 IVF failures, are most encouraging because the pregnancy rate for these teams after just endometrial local injury (EB after 2 IVF failures) is well above their usual pregnancy rate. Some teams have focused on immunoassay of endometrial biopsy, in order to profile uterine receptivity and suggest with results, suitable treatment for each patient (ongoing study). EB is quick, easy, make in a simple consultation and with a low cost, contrary to immunological study, which depend of ultra-specialized laboratories and therefore with an important cost.