Trials

BACKGROUND: Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. There is little evidence available for the curative setting after fistula occurrence. We hypothesize that EN increases the 30-day fistula closure rate in PUGIF, allowing better health-related quality of life without increasing the morbidity or mortality. METHODS/DESIGN: The NUTRILEAK trial is a multicenter, randomized, parallel-group, open-label phase III trial to assess the efficacy of EN (the experimental group) compared with TPN (the control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation) in terms of the 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate at 6 months after randomization, the fistula-related complication rate at 6 months after randomization, the type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month postrandomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 postrandomization, the mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment. A total of 321 patients will be enrolled. DISCUSSION: The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03742752. Registered on 14 November 2018.This research program is funded by the French Ministry of Health through Programme Hospitalier de Recherche Clinique 2016

Dérivés polycycliques aromatiques de type rétinoïde, leur procédé de préparation et leur utilisation pour la fabrication de compositions pharmaceutiques et cosmétiques.

info:eu-repo/semantics/publishe

Indoor tanning: motivations and beliefs among users and non-users in the population of Lille (Northern France)

BACKGROUND: Uncontrolled use of tanning beds is a major public health problem. The role of UV in skin carcinogenesis has in fact been clearly demonstrated. AIMS: The main purpose of the study was to assess the motivations and beliefs of the population concerning the use of indoor tanning. The secondary objectives were to compare the knowledge of users and non-users and to screen for addiction criteria among users. PATIENTS AND METHODS: This was a transversal descriptive study conducted between April and June 2013 in Lille town center. The motivations of the participants were determined using a multiple-choice questionnaire. A Likert scale was used to assess beliefs and an m-CAGE questionnaire was used to screen for addiction. RESULTS: Of the 200 respondents, 30% (n=60) had used tanning beds in a non-medical setting. The median age of first use was 23 years (15-59). 11.7% of respondents had started before the authorised age of 18 years. "To prepare the skin for exposure to the sun" was the main reason given (68.3%) for use of tanning beds. The population was aware that use of such apparatus favours onset of skin cancer and ageing of the skin. Users were more convinced than non-users that UV cabins "prepare the skin for exposure to the sun" (75% vs. 49.6%, P=0.0009) and that they "favour skin cancer" (56.9% against 36.2%, P=0.0444). Addictive behaviour was detected in 3.3% (2/60) of users. CONCLUSION: Users are aware of the carcinogenic risk of UV cabins but expose themselves to such risk, as they believe it prepares their skin for sun exposure

Aromatic polycyclic retinoid-type derivatives, method for preparing same, and use thereof for making pharmaceutical and cosmetic compositions.

info:eu-repo/semantics/publishe

International prognostic scoring system for Waldenstrom macroglobulinemia

Fue uno de los primeros pasos para lograr aunar al grupo internacional de MW, que ha proporcionado numerosos beneficios a los pacientes con esta enfermedad, transformando una neoplasia maligna en una enfermedad crónica con igual supervivencia que la población general[EN]Recently, many new drugs have been developed for the treatment of Waldenström macroglobulinemia (WM). To optimize the treatment according to the prognosis and to facilitate the comparison of trials, we developed an International Prognostic Scoring System for WM in a series of 587 patients with clearly defined criteria for diagnosis and for initiation of treatment. The median survival after treatment initiation was 87 months. Five adverse covariates were identified: advanced age (>65 years), hemoglobin less than or equal to 11.5 g/dL, platelet count less than or equal to 100 x 10(9)/L, beta2-microglobulin more than 3 mg/L, and serum monoclonal protein concentration more than 7.0 g/dL. Low-risk patients (27%) presented with no or 1 of the adverse characteristics and advanced age, intermediate-risk patients (38%) with 2 adverse characteristics or only advanced age, and high-risk patients (35%) with more than 2 adverse characteristics. Five-year survival rates were 87%, 68%, and 36%, respectively (P < .001). The ISSWM retained its prognostic significance in subgroups defined by age, treatment with alkylating agent, and purine analog. Thus, the ISSWM may provide a means to design risk-adapted studies. However, independent validation and new biologic markers may enhance its significance.Inerfnational Waldenstrom's Macoroglobulienmia Foundation Hospital Universitario de Salamanca Universidad de SalamancaHospital Universitario de Salamanc

Cognitive disorders in parkinson's disease: confirmation of a spectrum of severity

International audienceBACKGROUND: Clinical presentation and progression of cognitive disorders in Parkinson's disease (PD) is heterogeneous. Our objective was to confirm prospectively a previous exploratory cluster analysis based on retrospective data that identified five cognitive phenotypes in PD.METHODS: A model-based confirmatory cluster analysis was conducted on the results of neuropsychological tests administered in 156 PD patients from two European movement disorder centers (Lille, n = 81; Maastricht, n = 75). The number of clusters was determined on the basis of statistical criteria as well as clinical plausibility. A factorial discriminant analysis assessed the quality of the clusters' separation.RESULTS: A five-cluster model was statistically superior and clinically the most relevant. These clusters can be described as follows: 1) cognitively intact patients with high level of performance in all cognitive domains (25.64%), 2) cognitively intact patients slightly slower than those in cluster 1 (26.92%), 3) patients with deficits in executive functions (37.18%), 4) patients with severe deficits in all cognitive domains, particularly executive functions (3.20%), 5) patients with severe deficits in all cognitive domains, particularly working memory and recall in verbal episodic memory (7.05%). The groups differed in terms of age, apathy and frequency of hallucinations that were all higher in the clusters with cognitive deficits, and the duration of formal education was lower in those groups.CONCLUSIONS: We confirm our previous exploratory analysis. Cognitive disorders in PD patients are heterogeneous and can be separated in five clusters ranging from patients with performance in the normal range to patients with severe disorders in all cognitive domains

The arcuate fasciculus in auditory-verbal hallucinations:Ameta-analysis of diffusion-tensor-imaging studies

Auditory-verbal hallucinations (AVHs) are associated with an impaired connectivity of large-scale networks. To examine the relationship between white-matter integrity and AVHs, we conducted a meta-analysis of diffusion-tensor-imaging studies that compared patients with schizophrenia and AVHs with matched healthy controls (HCs). Five studies were retained gathering 256 DTI data points, divided into AVHs (n=106) and HCs (n=150). The meta-analysis demonstrated a reduced fractional anisotropy in the left Arcuate Fasciculus (AF) of hallucinators (hg= -0.42; CI[-0.69,-0.16]; p<10(-3)). The current meta-analysis confirmed disruptions of white matter integrity in the left AF bundle of schizophrenia patients with AVHs