Project description:Primary objectives: L’objectif principal est d’évaluer le taux de patients sans échec de la stratégie expérimentale 16 mois après la randomisation.
Primary endpoints: Le taux de patients sans échec de la stratégie après la randomisation. L’échec de la stratégie est défini par: • Progression (définie dans chaque bras)* en utilisant les critères RECIST v1.1 ou• Décès (toutes causes confondues) ou• Toxicité conduisant à l’arrêt définitif d’un des produits de la chimiothérapie (oxaliplatine et/ou irinotécan) • Refus du patient de poursuivre la stratégie • Décision de l’investigateur d’arrêter la stratégie
Project description:Introduction: Patients with Gilles de la Tourette syndrome (GTS) may experience blocking tics (BTs) defined as recurrent, brief cessations of motor acts. The aim of this study was to assess the prevalence, age of onset, and clinical correlates of BTs in GTS patients. Materials and Methods: We performed a one-time registration study in a cohort of 195 consecutive GTS patients aged 5-66 years (mean age: 15.0 ± 9.2; 47 females, 24.1%). All patients were personally interviewed and examined. Results: At least one BT occurred at some point in the lifetime of 73 patients (37.4%) with a mean age of onset of 10.4 ± 5.9 years. BTs occurred an average of 4.8 ± 5.3 years after tic onset. The most common BT was cessation of walking (n = 59, 80.8%), followed by speech (n = 19, 26.0%), running (n = 18, 24.7%), and writing (n = 9, 12.3%). Most of the patients (n = 52, 71.2%) reported cessation of only one activity. Clinical associations of BTs included more severe tics, overall greater number of tics, and, to a lesser extent, higher age at evaluation and comorbid obsessive-compulsive disorder. Conclusions: BTs represent complex tics, early and common symptoms of GTS, and are associated with a more severe form of GTS.
Project description:Primary objectives: Analyser le profil de la réponse inflammatoire cutanée des patients traités par anti-EGFR et de rechercher le lien avec la réponse radiologique
Primary endpoints: Le critère de jugement principal est la variation du taux des différents marqueurs inflammatoires cutanés présents au niveau des biopsies cutanées pré et post-thérapeutiques en fonction de la réponse radiologique.
Project description:Inattention, impulsivity and hyperactivity are the primary behaviors associated with Attention Deficit / Hyperactivity Disorder (ADHD). Previous studies proved that peripheral blood gene expression signature could mirror central nervous system disease. This study determined if gene expression in blood correlated with inattention, hyperactivity/impulsivity rating scales and/or both in subjects with Tourette syndrome (TS).
Project description:Primary objectives: Estimar el efecto de la combinación de panitumumab con irinotecán en la tasa de respuesta tumoral, definida como respuesta parcial y completa según los criterios RECIST modificados, en sujetos con CCRm con KRAS no mutado y refractario a la quimioterapia basada en irinotecán
Primary endpoints: Tasa de respuesta objetiva (TRO) durante la fase de tratamiento con terapia combinada.
Project description:Gilles de la Tourette syndrome (TS) is a complex neurodevelopmental disorder characterized by the presence of motor and vocal tics as well as psychiatric comorbidities such as attention-deficit/hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), depression, and anxiety. The underlying cause of the disease is still unknown, but several lines of evidence suggest a paramount role of the dopaminergic system. Based on the clinical observation that cannabis-based medicine including cannabis and delta-9-tetrahydrocannabinol (THC, dronabinol) may improve TS, alternatively, an involvement of the endocannabinoid system (ECS) has been suggested. In this study we measured cerebrospinal fluid (CSF) levels of the two most important endocannabinoids "N"-arachidonoylethanolamine (AEA, anandamide) and 2-arachidonoylglycerol (2-AG), the endocannabinoid-like molecule palmitoyl ethanolamide (PEA), and the lipid arachidonic acid (AA) in a sample of adult patients with TS (n?=?20) compared with controls (n?=?19) using liquid-liquid lipid extraction and simultaneous quantification by liquid chromatography multiple reaction monitoring (LC/MRM). CSF levels of AEA (p?=?0.0018), 2-AG (p?=?0.0003), PEA (p?=?0.02), and AA (p?<?0.0001) were significantly increased in TS compared with controls. Levels of 2-AG correlated with the severity of comorbid ADHD (p?<?0.01). This is the first study, demonstrating alterations in the ECS suggesting an involvement of this system in the pathophysiology of TS. It can be speculated that elevated endocannabinoid levels either represent secondary changes in order to compensate for alterations in other neurotransmitter systems such as the dopaminergic system, are simply an epiphenomenon or, alternatively, represent the primary cause of TS.