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.
Fighting against the pain caused by the disease or by the diagnostic and therapeutic procedures for children is a daily and essential concern of health care in the pediatric sector. The quantification of pain is needed to effectively adjust analgesic therapy while limiting the side effects of treatment. Nowadays many scales are validated for children, but they are based on one-off measures and hetero assessments are often subjective and dependent on many factors including the presence of staff to children's sides. Recent developments in the analysis of the cardiac signal in real time under the influence of autonomic control, have led to the development of a new painful stress quantification index. A monitor has recently been developed and provides an index of nociception and analgesia (ANI index). The validation of this nociception index has not been validated for pediatric care in a sector where particular attention is given to control pain. The main purpose of this study is to show the consistency of the index compared to a validated pain scale and used routinely in non-sedated children hospitalized in pediatric intensive care units. The caregiver will have the opportunity to fine tune the effective treatment.
Front-Of-Pack (FOP) nutrition labelling, providing simplified information on nutritional content at a glance, in order to help consumer make informed choices, has been identified as of major interest by public health specialists of many countries. French health authorities are currently considering the endorsement of a FOP nutrition label, but no specific format has yet been determined. A more simplified FOP nutrition label has been put forward in France, the 5-Colour Nutrition Label (5-CNL). Recent data suggests that the 5-CNL FOP label is well perceived and understood by consumers. The introduction of a FOP nutrition labelling system has been identified as challenging in certain population groups, due to their lower level of nutrition knowledge and unhealthier diets. The aim of the investigators is to evaluate the impact of FOP nutrition labels on the nutritional quality of the shopping cart in an online experimental supermarket in various nutritionally at-risk populations. Two FOP systems will be tested to a control situation without FOP labelling: the Reference Intakes (RI), currently in use by some manufacturers and present in a portion of food products sold in France, and the 5-Colour Nutrition Label (5-CNL). Three 3 arm parallel arm randomized trials are designed, each targeting a specific population. The methodology and interventions are identical across trials. Trials will be conducted in: 1) Working adults between 30-50 years old with low income, 2) Students and 3) Older subjects with identified chronic diseases. The intervention consists in the application of FOP nutrition labels on all food products, either the RI label, currently in use in some products in France, and the 5-CNL label. A control situation with no FOP will also be used. Participants will be asked to perform a shopping session in an experimental online supermarket, in one of the three experimental conditions described. The main outcome will be the overall nutritional quality of the shopping cart, assessed using the mean Food Standards Agency Nutrient profiling system score of the items in the shopping cart.
Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.
The severity of the diabetic nephropathy is proportional to proteinuria rate and degree of renal interstitial fibrosis. Despite many treatments available today, diabetic nephropathy is responsible for a quarter of cases of end-stage renal disease (ESRD) requiring the use of renal replacement therapy or kidney transplantation. It develops as follows: chronic hyperglycemia of diabetes abyss renal glomeruli that allow proteins in the urine room. In response, the tubular epithelium produces monocyte chemoattractant protein-1 (MCP-1) that attracts monocytes circulating in the renal interstitium. Monocytes then differentiate into M1 or M2 macrophages. M1 macrophages increased MCP-1 production while M2 macrophages produce transforming growth factor beta (TGF-β) pro-fibrogenic. Renal fibrosis is negatively correlated with the glomerular filtration rate itself proportional to the number of nephrons. The decrease in the number of nephrons majorises secondarily proteinuria by the onset of focal segmental glomerulosclerosis lesions. Production of MCP-1 increases with the renal proteinuria because M1 macrophages earning kidneys reinforce the production of MCP-1, and fibrosis worsens because M2 macrophages infiltrate in turn kidneys and produce TGF -β. A way of limiting renal fibrosis would be to decrease renal monocytic infiltration by promoting the differentiation of monocytes towards macrophages M2. Although more numerous, M2 macrophages no longer benefit the kidneys because the decline of M1 macrophages decrease renal MCP-1 production. Ex vivo IL1-β orients the differentiation of monocytes towards macrophages M1 and IL-4 to M2. By cons in vivo, the differentiating factors are poorly known. It is remarkable that metformin and telmisartan increase M2 macrophages M1 macrophages and decrease, respectively, in humans and mice. Moreover, telmisartan reduces proteinuria more than losartan in diabetic nephropathy in humans and Metformin decreases the amount of TGF-β intra-renal mice. This effect of telmisartan is independent of the type 1 receptor of angiotensin II (AT1R) since it is not obtained with losartan. Telmisartan is a partial agonist of peroxisome proliferator-activated receptor gamma (PPARgamma), the working assumption is that telmisartan fosters the transition of monocytes to macrophages M2 form, and limit the recruitment of more monocytes in the kidneys and therefore proteinuria and renal fibrosis. To show this, it will be compared the ability of monocytes to differentiate ex vivo in M1 or M2 macrophages in diabetic nephropathy patients treated with losartan or telmisartan then it will characterize the role of PPARgamma in the monocyte / macrophage transition. Finally, it will be compared the urinary excretion of amino terminal propeptide of procollagen type 3 (PIIINP), considered a marker of renal fibrosis in patients receiving losartan or telmisartan.
The prevalence of type 2 diabetes is growing steadily. Patients with diabetes, cardiovascular complications (such as myocardial infarction (MI)) are more frequent and severe than in non-diabetic subjects. The anti-diabetic therapies available have little or no effect on the incidence of cardiovascular events. It is therefore urgent in diabetics develop new therapeutic strategies to reduce the occurrence of MI or limit the consequences. In the two weeks following MI, monocytes / macrophages are the most represented in the ischemic heart tissue cells. The infiltration by monocytes / macrophages after infarction MI is a two-phase process. In the first phase, monocytes / macrophages M1 promote digestion injured areas, and monocytes / macrophages M2 intervene to promote angiogenesis, collagen deposition and contribute to tissue repair. The optimal repair after myocardial infarction depends on effective recruitment of monocytes and macrophages M1 transition needed to digest the damaged tissue and M2 macrophages necessary for tissue repair. The balance between these two phenotypes M1 and M2 is controlled by different modulators, such as transcription factors, cellular miRNA and miRNA extracellular contained in the microvesicles (MVs). Interestingly, plasma MVs circulating essentially derived monocytes and platelets contain miRNA and are impaired by inflammation or during various pathological situations (such as IDM). Furthermore, metabolic disorders such as hypercholesterolemia (often associated with diabetes) affect the transition from M1 to M2 response and response delay cardiac repair. To date, the mechanisms that control the M1 / M2 transition at heart level are not elucidated. Moreover, the impact of diabetes, which leads to chronic low-grade inflammation, is not explored. Targeting the immune response by promoting the transition M1 / M2 after MI could be an innovative therapeutic approach. However, better characterization of the response of M1 and M2 macrophages after MI and the mechanisms by which they contribute to tissue remodeling and the effect of diabetes are needed. The goal is to study how the phenotypes / macrophage functions after MI are changed by diabetes and to determine the potential role of miRNAs contained in secreted MVs in the transition M1 / M2 after MI. Monocytes / macrophages from subjects with normal blood sugar or diabetes who underwent an IDM (10 per group) will be characterized phenotypically. Their ability to produce MVs will be analyzed. These MVs will be tested functionally for their ability to orient the polarization of healthy recipients monocytes. The content of these MVs in terms of miRNAs will be analyzed in detail. By bioinformatics analysis, some miRNAs of interest (based on their abundance and target genes) will be selected. These miRNAs are over-expressed in macrophages and MVs produced by these cells will be analyzed for their ability to modulate differentiation of monocytes recipients. Finally, the circulating levels of these miRNAs of interest will be measured after 1 year of IDM and will be correlated to the clinical phenotype of patients (recurrence, arrhythmias, heart failure). Ultimately, the goal is to identify VMs that can promote the differentiation of monocytes to an alternative phenotype and identify miRNAs responsible for this effect. This could help in the future, in a subject with impaired ability of monocytes to differentiate alternatively, can change by introducing the miRNA of interest to re-inject or inject MVs macrophage containing the miRNA of interest and thus correct the defect of differentiation.
Clarify the determinants of the construction of a Therapeutic Alliance (AT) between paramedical staff (nurses and caregivers ) and adult patients in a functional unit of full-time general psychiatric Whether the quality of Therapeutic Alliance influences the continued support outpatient , after completion of full-time hospitalization.
Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients
The management of chemotherapy-induced nausea and vomiting (CINV) has evolved in recent years and became less frequent. CINV include early (occurring within 24 hours of chemotherapy administration) and delayed (occurring within 4 days after chemotherapy) nausea and vomiting. Preventive treatment, such as Glucocorticoids, 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists and neurokinin 1 (NK1) receptor antagonists, are administered according to the classification in 4 grades of expected CINV - Very low: <10% occurrence of CINV; - Low: 10 to 30% occurrence of CINV; - Average: 30 to 90% occurrence of CINV; - High: > 90% occurrence of CINV. These treatments have been the subject of recommendations. Despite these available treatments, some patients still complain of vomiting, or more frequently nausea and loss of appetite. Meanwhile, Chinese acupuncture has proven effective on the prevention of CINV as complementary treatment, mainly in the acute phase and to a lesser extent in the delayed phase. The most common points are Pericardium 6 (wrist) treated with conventional acupuncture needles, electro-acupuncture or acupressure. Auriculotherapy (ear acupuncture) has proven effective on nausea of pregnancy and postoperative nausea, but, to our knowledge, there are no studies published on the effect of auriculotherapy on CINV. These complementary treatments have virtually no side effects. In our institution, a simple treatment of acupuncture (2 points Pericardium 6 treated) and auriculotherapy (2 auricular point treated) is regularly use in patients who present CINV despite preventive treatment and most of them are relieved. The investigators propose a clinical trial in this population to assess symptoms improvement in patients presenting CINV after their first administration of chemotherapy despite adapted preventive treatment. Experimental treatment with semi-permanent needles takes place during administration of the second session of chemotherapy. CINV are evaluated through the (MAT) score that measures the frequency and intensity of nausea and vomiting in the 24 hours following the session and during the 4 days after administration Chemotherapy. Multinational Association of Supportive Care in Cancer Antiemesis Tool (MASCC), Http://www.MASCC.org/.
Background / rational: Obesity is associated with significant comorbidities including type 2 diabetes (insulin resistance), heart disease, stroke, hypertension, sleep apnea syndrome, dyslipidemia, cancer, hepatobiliary diseases, orthopedic complications and psychosocial impact 1 . Peripheral neuropathy is a known complication in the type I and II diabetes and glucose intolerance and metabolic syndrome in 2. Outside of diabetes (type I and II) that are associated with cardiovascular risk high vascular, presence of metabolic syndrome constitutes in itself a well demonstrated vascular risk factor. Its definition requires the presence of three elements from the following 5: abdominal obesity (high waist circumference), high blood pressure, high fasting blood sugar, high triglycerides and / low HDL-cholesterol 3. This peripheral neuropathy predominantly affects sensory fibers of small poorly myelinated diameter (Aδ fibers and C) and autonomous sensory fibers and is called small fiber neuropathy 4. The cardinal sign of NAION is the presence of neuropathic pain but abnormalities in physical examination are often absent and conventional electromyography is faulted to make the diagnosis. These small fibers are also constituent of the autonomic nervous system and causes damage autonomic dysfunction that can manifest the cardiovascular system (hypotension, cardiac conduction disorders), digestive, sweat, sphincter. neuropathy of the diagnosis of small fibers is suggested clinically by the presence of neuropathic pain often contrasting with a normal clinical examination. The confirmation is based on electrophysiology with various techniques and quantification of intra-epidermal nerve fibers. Main objective / secondary: Primary objective : To determine the prevalence of a small fiber peripheral neuropathy in nondiabetic obese patients, by measuring skin conductance ion Chlorine (Sudoscan®) evaluating small fibers C autonomic Secondary objectives: - Evaluation of the prevalence of occurrence of peripheral neuropathy by Sudoscan® during follow-up after treatment of obese patients with bariatric surgery (months) M1, 3, 6, 9, 12. - Correlation of results obtained Sudoscan® quantitative sensory testing (QST) Thermotest® evaluating small sensory fibers Aδ, among non-operated non-diabetic obese patients and in the postoperative follow-up (months) M1, 3, 6, 9, 12. - Characterization of electromyographic parameters (motor and sensory conduction) in patients with a skin conductance measured by lowered Sudoscan® and / or a threshold of sensitivity to pain increased Thermotest®. - Correlation between the presence of a small fiber neuropathy in non-diabetic obese subjects with clinical and biological parameters collected. Methodology Design: prospective, single-center Study duration: 24 months (estimate: 3-5 patients included / week of 15 patients collected in central obesity / week) including 12 months of inclusion. Number of topics to include: 100 over a period of one year to adjust to the rhythm of the inclusions. As mentioned, patients will be a measure of impedance of the skin to products chlorine ions by the sweat glands via the Sudoscan®, marketed and used among diabetic patients or not for the detection of violations neuropathic (cf. references and CE certificate attached to the dossier). The Thermotest® is also marketed and used in diabetic and non-diabetic patients (see references and CE certificate attached to the dossier). Our center has gained experience of these techniques for the detection of peripheral neuropathy in several patient populations (diabetes and cancer in particular); manipulators (doctors and technicians) are trained in these techniques.
This is a biomedical study on a medical device. 120 patients will participate in this study and will be split into 2 groups: - 60 patients in the "usual care" group: these patients will receive the usual care proposed by their doctor for 12 months. - 60 patients in the "ODRA" group: these patients will wear the ODRA brace for 12 months in addition to their usual care. They will be instructed to wear the brace for at least 6 hours per day, 5 days per week and to take it off during rest periods when lying down. The distribution of patients in the groups will be randomized. For this study, patients will be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6 months and 12 months.