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.
Hand osteoarthritis (HOA) which affects the interphalangeal joints and the metacarpophalangeal of the thumb is a common disease, the prevalence of which being about 30 % of the population over than 70. Some forms of HOA are refractory to usual treatments (analgesics, NSAIDs, local injections) and can lead to a high disability. In vitro and in vivo studies showed that IL-6 is involved in the OA process. The aim of the present study is to assess the efficacy of an Interleukin-6-Receptor Inhibitor (tocilizumab) on pain and function in patients with refractory hand OA.
The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.
The purpose of this study is to assess the therapeutic efficacy of transcranial magnetic stimulation in patients with depersonalization disorder.
Desmoid tumors (DT) are rare tumors (2-4 cases/million/year) that originate from musculoaponeurotic structures. Although they are benign tumors with no metastatic potential, DT are considered as locally aggressive tumors, with local invasiveness and tissue destruction, leading to pain, and disability. Surgery remains the keystone of therapy, but is limited by the anatomical situation of extra-abdominal desmoid (EAD) tumors (chest wall, root members). In patients where surgery is considered, negative-margin resection (R0) is recommended, but this frequently results in cosmetic/functional impairment. Moreover, prognostic impact of R0 resections remains controversial. The outcome after initial surgery depends upon several factors such as age, tumor site, and tumor size as demonstrated by recent data from the French Sarcoma Group. Alternative therapies to DT surgery for front-line or recurrence include NSAID's, anti-estrogens alone or in combination, -interferon, chemotherapy, targeted therapies or radiation therapy. All of these medical approaches however may fail to achieve long-term disease control and a number of patients suffer from irreducible pain, and disability from tumor volume. Cryoablation is a promising technique that is suitable for patients experiencing extra-abdominal DT. The procedure is based on repeated cycles of freezing/passive thawing of the tumor, leading to cell death. The technique has many advantages, among which: the accurate control of iceball under real-time MRI or CT-scan monitoring (that is not possible with other techniques such as radiofrequency), the lack of mutilation, the possibility of repeating the procedure. The cryoablation procedure has proven to be beneficial for the treatment of various tumors (liver metastases, breast, kidney). Recently, percutaneous cryotherapy has been reported in the treatment of EAD tumors poorly suited to surgery, with promising results. In the light of these encouraging data, it is believed that patients with extra-abdominal DT not amenable to surgery unless unacceptable surgical sequel and progressing after at least two lines of adequate medical therapy (tamoxifen, NSAID or chemotherapy), could benefit from the cryoablation procedure. Tumor cryotherapy-induced regression should allow symptoms relief, prolonged progression-free survival and a better quality of life.
The purpose of the present study is to compare the adjunct treatment of metabolic or mixed severe acidosis in the critically ill using Sodium Bicarbonate as a buffer to increase the plasma pH vs no buffering therapy. The study is a randomized multiple center clinical trial with the outcome as a primary endpoint.
The purpose of the study was to investigate the correlation between the nucleosome concentration and the rate of recanalization after thrombolysis. All patients were admitted to the Stroke Unit at the University Hospital Sainte-Anne where they received standard stroke care. The investigators included all patients treated or not by intravenous thrombolysis for anterior circulation stroke with or without vessel occlusion. Exclusion criteria were neoplasms, chronic inflammatory diseases and cytostatic therapy at the time of stroke and stroke-specifics symptoms that had started earlier than 4.5 hours before admission.
Primary Objective: To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to alirocumab ahead of commercial availability and to document the overall safety and tolerability of alirocumab in this participant population. Secondary Objectives: To document the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels as well as non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (total-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels after 12 weeks of treatment. To document participant's acceptability of self-injection (Self Injection Assessment Questionnaire, SIAQ).
Despite the large therapeutic arsenal available since one decade allowing a strong reduction of inflammation process, rheumatoid arthritis (RA) patients claimed pain, fatigue, sleep problems and other quality of life outcomes. Fatigue reduction during TNF blockers therapy is lower than the strong reduction in RA disease activity. Furthermore, RA patients have higher prevalence of non-inflammatory pain than general population. Fatigue is a real major problem due to 50% of patients considered it as severe. This dissociation between disease activity and fatigue level suggests that fatigue is multifactorial. No consistent explanations for fatigue are currently available.
Portal hypertension (PHT) that leads to esophageal varices is clinically present, at the time of diagnosis, in 60% of cirrhotic patients (Groszmann NEJM 2005). Variceal bleeding is a life-threatening complication. The yearly incidence of the first variceal bleeding in cirrhotic patients is estimated to 4%. This risk increases to 15% when medium or large varices are initially present, (D'amico Baillieres Clin Gastroenterol 1997); Therefore, for patient with medium or large varices a primary prophylaxis treatment with nonselective beta-blockers must be instituted decreasing risk of bleeding approximately by half (d'amico Hepatology 2005). The method to evaluate the efficacy of beta blockers treatment is the hepatic venous pressure gradient (HVPG). HVPG < 12 mmHg or a decrease of HVPG of 20% after beta blocker treatment reduce dramatically the risk of bleeding (Feu F. Lancet 1995). But a good response (HVPG < 12 mmHg or reduction > 20%) to beta blockers was observed only in almost 30 % of patients. In non responder patients, the variceal bleeding incidence is estimated to 24 % at 2 years. In this situation, alternative treatments to beta-blockers have been suggested: endoscopic ligation, which was shown to be as effective as beta blockers in primary prevention, and more recently carvedilol (Reiberger, Gut 2012). So, HVPG monitoring may provide critical information for patients. However, because of its technical requirement and its invasivity, HVPG measurement is not feasible in clinical practice . So, there is a general consensus to continue indefinitely beta blockers treatment without control of hemodynamic efficiency (merkel J. Hepatology 2009). Previous studies have suggested the interest of azygos blood flow measurements for evaluating hemodynamic changes in the esophageal collateral vessels of patients with portal hypertension (Bosch J. Hepatology 1985 ). More recently Magnetic Resonance Imaging (MRI) has been reported to be an efficient technique to assess azygos blood flow (Gouya Radiology 2011) in cirrhotic patients. Its feasibility is obviously higher than HVPG measurement. However, in the same way that HVPG, a large-scale implementation in clinical practice of azygos blood flow measurement by MRI requires to specify minimal absolute threshold, or relative post-therapeutic decrease, related with no variceal bleeding.
Diaphragmatic dysfunction is associated with sepsis severity and pejorative prognosis. Aim of this study is to assess diaphragmatic function with the Diaphragmatic Thickening Fraction (DTF) ultrasound measure in patients with severe sepsis or septic shock, mechanically ventilated or not, hospitalized in ICU in order to determinate diaphragmatic dysfunction frequency, its prognosis value and its associated factors. This is a prospective pilot study in a 14-bed medical and surgical ICU including 50 consecutive patients with severe sepsis or septic shock. The expected duration of study is 18 months. DTF is measured each day as follow: the probe is placed in an intercostal space between mid axillary line and anterior axillary line, 0.5cm to 2 centimeters below the costodiaphragmatic sinus. DTF measure is performed in B-mode using the following formula: TF (%) = [(end-inspiration thickness - end-expiration thickness)/(end-expiration thickness) x 100]. A DTF < 20% indicates a diaphragmatic dysfunction. The investigators will collect potential factors for which DTF Ultrasound Measure could have a prognosis value (intubation, successful or failed weaning from mechanical ventilation), potential risk factors (age, sex, tobacco, alcohol etc.) and potentials associated factors. The investigators expect measure of DTF allows identifying patient with severe sepsis or septic shock with diaphragmatic dysfunction. It would also estimate diaphragmatic dysfunction frequency with ultrasound measure and warranting its use routinely at the bedside. The investigators expect that DTF helps to characterize degree of severity of septic patient and can be a new index able to predict intubation in this population.