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 is a prospective, single-center, non-randomized study of immediate breast reconstruction (IBR) using a pre- or retro-pectoral technique in patients with breast cancer who have undergone total mastectomy. The technique used is chosen according to the characteristics of the breast, the morphology of the patient and her wishes after informed information on the different techniques. The aim is not to compare the two techniques but rather to evaluate the early functional results of these two methods in order to better understand them and to propose a management adapted to each. The main objective will be to evaluate the postoperative pain by BPI questionnaire. The investigators also wish to observe the functional results of the homolateral upper limb by DASH questionnaire, the quality of life by BREAST Q questionnaire and the occurrence of complications.
In a study published in 2018 the research team had collected the Medical Research Council score (MRCs) at Intensive Care Unit (ICU) discharge. The investigators would like to be able to examine, if the preliminary results obtained by in 2020 by Van Aerde's team are confirmed in their cohort. The investigators hypothesize that patients with an MRCs less than or equal to 55 at discharge from the ICU, have a higher mortality rate than those with a score greater than 55. The investigators would also like to examine whether or not an MRCs score ≤ 55 is associated with a difference in quality of life and autonomy, after 5 and more years post ICU.
Accurate assessment of pain in Pediatric Department is challenging. However, recent publications highlight that children do not receive optimal pain management, particularly in Emergency Departments. An Artificial Intelligence-based tool could help physicians to optimize analgesia use.
The Vascular Access Unit (UAV) of the Lyon Sud Hospital Center is the first unit within a French public establishment where the Regional Health Agency (ARS) has authorized that medical procedures for the installation of central venous access be performed by nurses. The installation of CIP represents an anxiety-provoking step for the patient, because the gesture, which consists of inserting a box under the skin, connected to a catheter, placed in a deep vein, involves uncomfortable, even painful moments. In the UAV, the installation of this device is carried out in the operating room, without premedication and only under local anesthesia. Affected patients usually have a diagnosis of serious illness (oncology). Virtual Reality (VR) simulates the physical presence of the patient in an environment artificially generated by software. Many applications have already been evaluated in different health sectors, the investigators would like to show its interest in reducing patient anxiety during CIP placement under local anesthesia, without premedication. The medical device used is Lumeen. It is a Class I medical device software within the meaning of Regulation (EU) 2017/745, CE marked. In the context of research, the Relaxation module is used. This module is the one intended for the management of anxiety and pain induced by medical procedures in adults and children over 6 years of age. It allows to perform immersions in 360° videos in real shots or computer-generated images, accompanied by natural sounds, relaxing music and a relaxation script recorded by hypnotherapists. The duration of an immersion can be adjusted according to the needs of the medical procedure..
Malaria remains the world's leading parasitic endemic. Almost half of the world's population lives in endemic areas. Many at-risk people in African countries remain without access to malaria control. Malaria kills approximately 400,000 people each year, most of whom are children under the age of 5 in Africa. Since 2005, an increasing number of Plasmodium vivax infections have been observed in Duffy-negative populations in South America and Africa, calling into question the essential role of the PvDBP-DARC interaction. The objective of the investigators is therefore to study and understand the invasion pathways used by Plasmodium vivax in Duffy-negative subjects.
Background : Segmental spinal instability after a laminectomy, and adjacent segment disease (ASD) at after an arthrodesis, are well-known concerns in spinal surgery, which may require re-interventions, usually by surgical arthrodesis, posing the problem of a new heavy intervention under general anesthesia, in often fragile patients. Trans-facet fixation (TFF) under local anesthesia and double fluoroscopic and CT guidance is a minimally invasive technique involving the placement of screws through the posterior facet joints, improving spinal stability. Purpose : The aim of our study is to evaluate the efficacy, in terms of pain reduction (VAS) and improvement of daily activities (ODI), of TFF under CT scan guidance in the context of low back pain and/or radiculalgia related to focal instability secondary to laminectomy or ASD. Methods : TFF were performed in 24 patients having a history of spinal surgery such as laminectomy and/or classic surgical arthrodesis and remaining symptomatic, at Nice University Hospital between 2017 and 2021 Pre- and postoperative pain and disability levels were measured using the visual analogue scale (VAS) and the Oswestry Disability Index (ODI), collected prospectively at systematic 6-month and 1-year follow-up visits. Long term evolution were assessed by phone consultation.
Dry eye affects millions of people around the world. Some dry eye patients complain of neuropathic eye pain that can affect their quality of life. From August 2016 to June 2017, the QUALVIDON study (NCT03296111), conducted at the Adolphe de Rothschild Foundation Hospital, assessed pain and its impact on quality of life using self-administered questionnaires in a series of dry eye patients. This 2nd study, entitled QUALVIDON2, focuses on the outcome of patients previously included in QUALVIDON.
This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage). Therefore, its objectives were as follows: - To assess functional clinical score's evolution, - To evaluate patient's satisfaction - To confirm safety of varisation staples The target population for this study was any adult patient implanted with VEOFIX varisation staples in their intended uses between 15/02/2021 and 15/05/2021. Patients were implanted and followed as per standard of care led in the investigational site. The following regulation and guidelines were followed for this investigation: - Standard ISO 14155:2020 "Good Clinical Practice"undirectly applicable; - Regulation (UE) 2016/679 (RGPD) ; - Regulation (UE) 2017/745 (MDR) ; - MEDDEV 2.12.1; - Local regulation (loi " jardé ", loi " informatique et libertés "). As per its design, the investigation is considered as involving human beings, and therefore require submission to an ethic committee or declaration to a Competent Authority (ANSM) and CPP. This study was registered on CPP (CPP Ile de France VII).
In 2005, colorectal surgery in France represented nearly 40,000 procedures per year, of which 80% were scheduled and 70% were for carcinological purposes. Overall postoperative mortality was estimated at 3.4%, morbidity at 35% and average length of stay at 18 days. In addition, the number of newly diagnosed cases of colorectal cancer was 44,872 in 2017, making it the second leading cause of cancer in women and the third in men. The implementation of colorectal Enhanced Rehabilitation After Surgery (EARS) programs has resulted in a significant reduction in length of stay due to an approximately 50% decrease in postoperative complication rates and a faster return of patients to independence. However, despite the integration of RASC into routine practice, morbidity remains high with an estimated complication rate of 15-20%. The persistence of a high complication rate despite the rehabilitation measures can be explained in part by factors present preoperatively that impair postoperative recovery, such as the existence of comorbidities, low functional capacity, the presence of martial or nutritional deficiencies or glycemic imbalance. Links between the presence of these different "deficits", which may coexist, and postoperative morbidity and mortality have already been shown. Anemia is common in preoperative colorectal surgery and affects approximately one in two patients with cancer. In case of preoperative anemia, the frequency of postoperative complications and the length of stay are increased. Under these conditions, preoperative correction of anemia could facilitate postoperative recovery and reduce the incidence of postoperative complications. In colorectal cancer, anemia is the consequence of an absolute martial deficiency due to iron losses from bleeding and a functional martial deficiency due to decreased availability of iron for erythropoiesis due to inflammation. Correction of preoperative anemia is usually based on 2 types of molecules: iron and erythropoiesis stimulating agents. Erythropoiesis-stimulating agents are not recommended to correct anemia in cancer patients not receiving chemotherapy. Iron can be given orally or intravenously. Intravenous administration is more effective than oral administration in patients with colorectal cancer to correct preoperative anemia. In patients undergoing colon cancer surgery outside of a RAAC program, preoperative iron infusion appears to decrease the incidence of postoperative complications, improve the quality of postoperative recovery, and reduce length of stay. These gains do not appear to be related to correction of preoperative anemia, since preoperative intravenous iron increases hemoglobin levels by only 0.8 g/dl, on average. And, insufficiently to reduce the rate of postoperative transfusion in abdominal or general surgery. Also, the benefits observed with preoperative iron infusion seem to be more related to the direct effects of iron on cardiac and skeletal muscle than by correction of anemia. Since 2016, all patients undergoing scheduled colorectal surgery at the Paris Saint Joseph Hospital Group benefit from the application of a RAAC program. If we do not take into account patients who die during hospitalization (≈ 2%) and patients transferred to Follow-up and Rehabilitation Care (SSR) (≈15%), the impact of the application of a RAAC program is easily measured with the length of stay. Indeed, reducing the frequency of postoperative complications and improving the speed of postoperative recovery translates into reduced lengths of stay. Today, the average length of stay for all patients undergoing colorectal surgery at Saint Joseph Hospital is 7.5 days. The length of stay is longer (8.7 days) in patients with anemia preoperatively compared to those without anemia (7 days). Since 2017, anemic patients scheduled for colorectal surgery, have received intravenous iron infusion preoperatively at Paris Saint Joseph Hospital.
Assess the effect of exposure to a situation of social exclusion or ostracism on the prospective memory of children with ADHD