All clinical trials

The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology, in particular for cancers of the upper aerodigestive tract. In the case of pharyngeal and laryngeal cancer, total laryngectomy associated with radiotherapy remains a reference treatment for advanced stage cancers. This mutilating surgical procedure has a major impact on the patient's life, due to its physical and functional sequelae. Its psychosocial consequences are also important, owing to the biographical disruption and the identity-related metamorphoses associated with illness and its treatment, which alter the quality of life not only of patients, but also of their close relations. Currently, care for laryngectomised patients consists essentially in informing and educating them on certain technical procedures during hospital admission. New voice education can be a long process and often involves the intervention of a speech therapist, who serves as the link between the patient and the hospital care team. These healthcare modalities often insufficiently account for the social, environmental and personal factors that interact in health-related problems. The aim is to design, implement and evaluate a patient therapeutic education (PTE) programme, for laryngectomised patients and their close relations, aimed at improving their quality of life. The research will be conducted over three phases: The first phase, referred to as the "pilot" phase, will include exploratory, observational and retrospective analysis aimed at developing knowledge on the consequences of laryngectomy on the quality of life of patients and their close relations, the strengths and weaknesses of current practice in patient support and the needs expressed by the players involved (patients, relations, professional carers). This analysis will be conducted via interviews with patients and their close relations and focus groups with the healthcare professionals involved in patient care and support (hospital and independent). This first phase will enable the pluridisciplinary design of a therapeutic education programme for laryngectomised patients and their close relations which will be tested in the study's principle coordinating centre. The method defined thus is in keeping with quality criteria set by the HAS specifying that the PTE should focus on the patient, be scientifically justified, and be developed by a pluridisciplinary group reuniting representatives of patients or patient associations. The second phase, referred to as the prospective intervention "replication" phase, aims at evaluating the programme's transferability and quality in three centres. The centres participating in this second phase already have experience in the development of PTE programmes and will be involved in the workgroup entrusted with the design of the PETAL programme during phase 1. The third phase, referred to as the "randomised" multicentric comparative intervention phase, should enable us to assess the benefits of the developed PTE programme on the quality of life of patients and their close relations. This is a pluridisciplinary study via which we hope to improve the quality of life of laryngectomised patients and their close relations through the design and the sustainable deployment of an innovative PTE programme in France and Belgium. This project also aims at reinforcing town-hospital links to improve help, follow-up and support for patients and their close relations, as well as dialogue between healthcare professionals.

This is a follow up study which aims to evaluate the correlation between several methylated genes (potential biomarkers) and oral cancers. A prospective case control trial is designed with sample size of at least 300 cases with estimated 200 subjects with precancerous lesion or oral cancer, and 100 subjects with normal oral mucosa. This study is approved by the National Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all subjects will receive an intraoral examination and followed by epithelial cells collection with oral swab. The gDNA will be extracted from the oral swab collected cells and followed by bisulfite conversion procedures. Subsequently, bisulfite converted DNA will be subjected to methylated gene detection by Real-Time PCR. The methylation index (clinical sensitivity and specificity) of oral cancer related genes will be evaluated. For diagnosis confirmation, photos and biopsy specimens will be taken upon observation of abnormal lesion.

Cardiac surgery patients have many risk factors for endothelial dysfunction (hypertension, atherosclerosis, dyslipidemia, chronic renal failure ...). It is likely that a significant number of patients suffering from a preexisting endothelial dysfunction. This endothelial dysfunction can be assessed by a molecular approach (determination of NO, ICAM1, VCAM1, IL8, endothelial microparticles ...). Extracorporeal circulation with ischemia-reperfusion causes a breach of particularly important glycocalyx as ischemia-reperfusion injury is. No studies have evaluated the time course of the infringement, and its association with the immediate post-operative complications (SIRS, coagulopathy, vasoplegic syndrome, renal failure). Only one study has regained an association between endothelial dysfunction during cardiac bypass surgery and postoperative cardiac surgery vasoplegic syndrome. A study in noncardiac surgery has regained an association between endothelial dysfunction (assessed by a vasoplegia test) and postoperative acute renal failure. Thus there is some data in the literature to suggest that the occurrence of postoperative complications (SIRS, coagulopathy, capillary leak syndrome, acute circulatory failure vasoplegic and acute renal failure) may result from the interaction between a pre-existing endothelial dysfunction and "operative" aggression (extracorporeal circulation). The onset of complications result from an interaction that depends on the importance of endothelial dysfunction at baseline.

Thirty healthy individuals will be participants of the study. Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, will be recorded. Postural sway and limits of stability parameters will evaluate with computerized balance evaluation system (BERTEC) for seven times .

It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment syndrome. the aim of this study is to assess the qualities of a predictive score on the occurence of this syndrome after surgery of ruptured aortic aneurysm

Infective endocarditis (IE) is defined as a bacterial infection of the endocardium (inner surface of the heart), which may include one or more heart valves. Epidemiologic pattern has changed during the last 20 years whereas the incidence was unchanged. However, the mortality increase despite recent diagnosis and therapeutic advances. Only few investigations consider the prognostic and the therapeutic medical care according to the clinical care pathway. In fact, 3 situations are observed: (i) patient for whom diagnosis and medical care are realized in a referent center with cardiac surgery, (ii) patients secondary addressed to a referent center with cardiac surgery, (iii) patients for which the totality medical care are performed in non-referent health center. In addition, epidemiologic studies concern only a part of IE, not including most of the time the patients hospitalized in non-referent center. The aim of the study was to determine the prognosis of threated patients according to the clinical care pathway. Secondary objectives was (i) to evaluate the application of European recommendations concerning trans-oesophageal echocardiogram (TOE), antibiotic treatment and surgical practice, (ii) to compare the epidemiologic profile according to the type of center. For this, 300 patients addressed in the 22 French participating centers for a possible or certain IE according to Duke Criteria were prospectively included during 3 years. Patient data (clinical, demographical, biological, microbiological, echocardiographic and evolutive data) were collected at the admission, during hospitalization, at discharge and one-year follow up.

Determining the LV filling pressure is a key element in the diagnosis and management of patients with suspected decompensated heart failure. The aim of the present study is to assess whether a systolic 2D-STEderived parameter, global longitudinal peak systolic strain (GLPSS), acquired by transoesophageal echocardiography (TEE) is superior to the E/Ea ratio in the estimation of the LVFP measured as the pulmonary capillary wedge pressure (PCWP) in patients during cardiac surgery. Automated function image (AFI) algorithm is a novel method based on 2D strain imaging that enables the simultaneous quantification of myocardial strain in different left ventricular segments; its 3-click method minimizes variability related to a manual training of endocardial border required in an usual 2D-strain analysis. AFI provides GLPSS by averaging mid-oesophageal 4-, 2- chamber and long axis views. The study is a prospective observational single-center cohort study. 30 Patients scheduled for elective cardiac surgery will be included in the study group. The study is designed to assess whether GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of LVFP measured as PCWP.

Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for non metastatic colon cancer.

Investigators are seeking to determine the impact of recent alcohol, smoking or psychotropic drug use prior to intensive care unit (ICU) admission on incidence of delirium and sedation requirements. Study design: A prospective observational study, in a medical ICU of a tertiary university hospital. Methods: For all new ICU admissions, a 1-page questionnaire including Alcohol Use Disorders Identification Test (AUDIT-C), smoking history and prior medication use was given to the patient or closest family members. Delirium was assessed by trained ICU nurses using Intensive Care Delirium Screening Checklist and Richmond Agitation-Sedation Scale.

The new definition of sepsis (sepsis 3.0) restricts the early diagnosis of sepsis in general wards. Despite an alternative process by using a simplified qSOFA score, many patients may still be left out. Whether these patients matter or not is unknown. This prospective cohort includes patients from ten general wards with high incidence of infection during a consecutive half year, obtains qSOFA and SOFA score, follows up prognostic data, therefore to compare patients under different groups, eventually to evaluate the diagnostic accuracy of qSOFA score in diagnosis of sepsis.