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.
This multicentre, prospective, randomized, open-label study will compare the safety and efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation of cyclosporine, with those of mycophenolate mofetil and long term continuation of cyclosporine in renal transplant recipients receiving daclizumab (Zenapax) as induction treatment and followed by 8 month treatment with corticosteroids. The anticipated time on study treatment is 12 months. Participants who will complete the initial 12-month study and who will provide written informed consent will be eligible to participate in a 60-month follow-up phase.
This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose escalation design to explore the safety and assess the recommended phase 2 dose of Brentuximab Vedotin in Hodgkin lymphoma patients treated with ICE regimen. The second part, depending on the selected dose after the completion of phase Ib part of the study, will further explore safety in addition to efficacy of the recommended dose of Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin lymphoma.
Background: Management of patients with Alzheimer's disease associated with behavioral disturbances is difficult especially in those with agitation/aggression and insomnia and nighttime behaviors. No treatment has shown any efficacy to control these disturbances and psychotropics drugs, i.e. sedatives and hypnotics have numerous adverse effects. Objective: Assess the effect of bright light therapy on behavioral disturbances of patients with Alzheimer's disease, especially the effect on agitation/aggression and insomnia and nighttime behaviours. Study design: Multicenter non pharmacological intervention trial, controlled, randomized, open, two-arm design : control group and intervention group. Centres : Rehabilitation and long term-care units of 4 geriatric hospital wards. Patients: 120 patients admitted in geriatric hospital wards (30 by centre), with probable Alzheimer's disease according to DSM-IV diagnosis criteria and agitation/aggression (associated or not with insomnia or nighttime behaviors) according to the Neuropsychiatric inventory, nurse scale (NPI-nurse). Treatments: Intervention group: patients will participate in a program of bright light therapy realised during a one-hour sessions of occupational therapy,. These sessions will be realised for groups of 6 patients and will be done every week day, at late morning, for 4 consecutive weeks). During the session, patients will be exposed to 10000 lux-bright light. Patients of control group will participate in a program of occupational therapy of same duration and rhythm, realised in standard light conditions (about 300 lux). Assessment: Patients with be assessed on 3 occasions: inclusion, two and four weeks after the beginning of the programs. Assessment will comprise ; NPI-nurse scale and Cohen-Mansfield scale for behaviour disturbances, wrist actimetry for sleep and nighttime behaviours (total sleep length, nocturnal wake episodes and nocturnal motor agitation). Judgment criteria: Principal: changes in the agitation/aggression item of NPI-nurse scale. Secondary: changes of the nightime behaviours item of NPI-nurse scale, the Cohen-Mansfield, total sleep duration and numbers of nocturnal wake episodes measured by wrist actimetry. Statistics: Changes in agitation/aggression scores od the two groups will be compared by Mann and Whitney test. Expected results and perspectives; If bright light exposure is efficient, professional caregivers of Alzheimer's disease patients might apply this cheap and non pharmacological approach to improve behaviour and sleep of these patients. This study might contribute to better define the place of a non invasive and promising technique, wrist actigraphy, to assess sleep and behaviour disturbances in psychogeriatric patients
GLP-1 receptor agonists are introduced in the treatment of type 2 Diabetes (T2D) and their efficacy is documented. However, safety aspects are also important to evaluate with respect to micro and macrovascular complications associated with T2D. Few studies have properly addressed the role of GLP-1-based therapies in regulating vascular integrity and angiogenesis. The study evaluate the impact of one-month treatment Liraglutide on both ANGPT2 and ANGLPT4 levels and endothelial circulating progenitor cells, angiogenesis biomarkers in type 2 diabetic patients.
While venous access is an essential part of caring for the preterm neonate potential severe adverse events, including contamination of fluids with bacteria, endotoxins and particulates could occur (Bethune 2001). Infusion therapy carries a risk for catheter-associated septicaemia (Geiss 1992) originated from the catheter tubing, the ports, at the cannula site or from contaminated infusion fluid. While not all infections lead to septicaemia, immuno-compromised patients such as neonates are at greater risk, and infection becomes a major problem (Ng 1989) and a major risk factor for neurodevelopmental disabilities (Volpe 2008). Indeed, it has been postulated that endotoxins may be involved in the pathogenesis of a proportion of cases of periventricular leukomalacia, the most frequent brain damage associated with neurocognitive handicaps in the human neonate (Volpe 2001). The presence of calcium in parenteral nutrition mixture leads to precipitation due to its incompatibility with the other components of the admixtures and leads to high concentration of particles (Athanasiou 2014). Adverse systemic effects of particulate matter including phlebitis, granulomata formation in the lung (Marshall 1987) and ischaemic necrosis, are a common finding in necrotizing enterocolitis another serious complication flowing preterm birth (Ballance 1990). Particle contamination of infusion solutions exists despite a stringent infusion regiment. The number and composition of particles depends on the complexity of the applied admixtures (Jack 2010). Particulate contamination is due to drug incompatibility reactions or their incomplete reconstitution during the preparation process (Schroder 1994). Various studies have demonstrated the contamination of infusion solutions with glass particles from opening glass ampoules, particles from rubber stoppers or conglomerates of the parenteral nutrition components (Ball 2003). Particles have also been shown to be inherent to generic drug formulation (Oie 2005). In an intensive care setting the particle burden may rise up to one million infused particles per day, increasing with the complexity and quantity of the administered infusions (Walpot 1989). There are two main IV filter pore sizes; the 0.2 micron filter is used for aqueous solutions, and the 1.2 micron filter is recommended for larger molecule solutions such as lipids. The 0.2 micron filter has also been reported to remove air, microorganisms and particulate matter. In addition, endotoxin retention is reportedly achieved by using a positively charged filter membrane; toxic macro-molecules are released by gram-negative bacteria and are claimed to be effective for up to ninety six hours (Bethune 2001). In-line IV filters are currently claimed to be an effective strategy for the removal of bacteria, endotoxins and particulates associated with intravenous therapy in adults (Ball 2003) and particularly effective in the removal of particles caused from drug precipitate such as antibiotics (Chee 2002; Ball 2003). However, evidence of the beneficial effect of in-line IV filters in children and neonates is much weaker, despite some positive studies (Jack 2012; Boehne 2013; Sasse 2015). In the population of preterm infants, no study is currently available while particulate contamination due to infusion therapy carries a higher health risk in this subpopulation. The benefits of using IV in-line filters in critically-ill preterm neonates remains to be demonstrated. This intervention in adults has also been challenged by several authors (Pearson 1996; Newell 1998). Friedland reported that certain drugs such as antibiotics may be retained in the filters causing a reduction in potency (Friedland 1985). On the other hand, there are no known adverse effects from the use of IV in-line filters.
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). The objective of this study was to compare the efficacy, safety, and patient reported outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands (SRLs).
Cardiac arrest remains a leading cause of death, currently affecting >250,000 Europeans outside the hospital each year. Manual cardiopulmonary resuscitation (CPR) provides between 15 to 30 % of normal blood flow to the heart and brain. For out-of-hospital cardiac arrest, the return of spontaneous circulation (ROSC) is possible only for 20-40% of patients with trained resuscitation teams. However, only 5-10% of patients will survive with good neurological status. A good quality CPR, a short time before initiation of the resuscitation and a short delay before the first defibrillation have been associated with improved neurological outcome. Unfortunately it is currently impossible to obtain reliable information on the quality of the perfusion and oxygenation of organs during CPR. The current monitoring during CPR is limited to heart rhythm analysis, pulse rate evaluation and end tidal CO2 (EtCO2). The last one is the only parameter which have been linked with probability of ROSC and its value gives no indication of the long-term prognosis nor the neurological status. Cerebral spectroscopy (near-infrared spectroscopy - NIRS) allows to measure with a noninvasive method the local oxygen saturation of the prefrontal cortex (rSO2), reflecting the balance between need and supply of brain oxygenation. This technique has been recently used in cardiac arrest showing a possible association between rSO2 measured during CPR and the occurrence of ROSC or survival. The quantitative measurement of the pupillary light reaction has been described to predict neurological outcome in the hospital for patient successfully reanimated after out-of-hospital cardiac arrest (OHCA). Recently, a feasibility study has shown that its use was also possible during CPR in the pre-hospital setting. The investigators aim to study a composite prognostic factor combining quantitative rSO2 and automated pupillometry measured during CPR. The investigators hypothesized that the rate of survival with good neurologic outcome at 30 days will be lower in patients with rSO2 <30% for more than 5 min and an absent pupillary reflex more than 5 min or decreasing during CPR .
Study objective is to assess the interest of the relational touch before an arterial puncture to reduce pain on patient in intensive care unit.
The purpose of this study was to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma (LGG) or relapsed or refractory high grade glioma (HGG)
For the replacement of the sternum, there is no consensus regarding the most appropriate and most effective physiologically material. The use of ceramic implant offers significant operational time saving and biocompatibility coupled with the strength of the material allow us to realize a more natural operation, limiting the risk of infection and rejection. Main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic implant on the respiratory capacity at 3 months post surgery.