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.
Currently, aspects related to the effects of anticancer treatments and the quality of life of patients and their needs are still poorly documented at the Rafael Institute. Thus this study will meet a dual objective: (1) the establishment of a registry to collect data on the safety and effectiveness of innovative and expensive anticancer drugs when administered in real life and (2) a measurement quantitative quality of life of patients treated with these drugs.
According to the literature, malnutrition affects between 30% and 50% of hospitalized patients. The most recent survey on the prevalence of malnutrition in hospitals in France dates back to 2003, and at the Pitié Salpêtrière Hospital to 2015. Malnutrition is a pathological process that can lead to complications for patients and prolong their length of stay. Main objective: Evaluate the prevalence of malnutrition in adult patients hospitalized on a given day at Pitié-Salpêtrière Hospital (PSL) according to HAS ( High Authority for Health) criteria for 2019 (if age <70 years) and 2021 (if age ≥ 70 years).
With the shift to ambulatory care and the rise of ATCO oral anticancer drugs, a growing number of cancer patients are benefiting from oral treatment in an outpatient setting, which meets their needs and preference over injectable chemotherapy with more autonomy and less time spent in the hospital. However, outside the safe hospital context, the complex pharmacological profile of ATCO exposes patients to iatrogenic drug risks. These medicinal problems or Drug Related Problems DRP linked to ATCO are sources of dosage modifications and lead to sub-therapeutic doses compared to clinical trials and consequently to a reduction, in life actual, dose-intensity and expected response. Furthermore, insufficiently controlled in an ambulatory environment and due to a lack of city-hospital coordination, DRPs lead to an increase in the consumption of care. Oncoral is the pioneering multidisciplinary city-hospital monitoring of outpatients treated with oral anticancer drugs. Set up in 2014 by the Hospices Civils de Lyon, this educational monitoring is based on a tripartite hospital intervention (oncologist, pharmacist, nurse) and a structured city-hospital link with private health professionals (attending doctor, community pharmacist and freelance nurse). Multidisciplinary interventions are focused on PROs and DRPs and combine an educational approach for the patient based on their needs and potential social vulnerabilities. The PACOME real-life database will describe the population of ambulatory patients treated by ATCO benefiting from the secure multidisciplinary city-hospital Oncoral pathway with the aim of improving knowledge on this population, on the real-life use of ATCO and on new methods of organizing ambulatory cancer care. The PACOME database collects sociodemographic, clinical and therapeutic data, and experiences in this population. Patients quality of life and other PROs (symptoms and adverse effects experienced by patients), social determinants, health care consumption, the caregiver-patient relationship, the use of digital technology in health, the organization of care, the city-hospital link (interventions of actors and their temporality). This base will make it possible to optimize the treatment of patients at the individual and population level and to generate evidence in addition to clinical trials, which are expected by health professionals and decision-makers. With patient data from the secure Oncoral pathway, PACOME brings together the three major and inseparable assets of real-life databases: quality, completeness and meaning of the data. It constitutes a basis for essential academic and private collaborations for studies on data and comparative observational or interventional studies, which will contribute to the animation of the new ecosystem of real-life health data in oncology.
In the ICU, scientific societies recommend starting enteral nutrition within 48 hours of admission, if oral nutrition is not available, in order to limit undernutrition. In patients who are sedated, have swallowing problems or cannot ensure adequate caloric intake, it is essential to insert a feeding tube, usually a nasogastric or orogastric tube for the first few weeks. Placement of a naso- or oro-gastric tube in the intensive care unit is a frequent procedure, and considered to be straightforward. It is usually performed blindly, at the patient's bedside, by a nurse or doctor, according to a departmental protocol or the recommendations of learned societies. Nevertheless, a number of complications have been reported with naso- or oro-gastric tubes, linked in particular to a route outside the digestive tract : malpositioning/coiling of the tube, epistaxis, sinusitis. The most frequent and potentially severe complications are malpositions in the tracheobronchial tree. Radiographic control is currently considered in France and by certain learned societies to be the reference method for verifying correct positioning of the probe in the stomach (at the prepyloric antral level). However, thoracic radiography has a number of drawbacks : In intensive care risk of accidental displacement of other medical devices,irradiation, difficulty of interpretation, delay in obtaining the image, time-consuming work for qualified personnel. An alternative technique using the NGPOD device is proposed as a method of checking the correct positioning of the probe in the stomach. This system enables immediate, rapid (15 seconds), simple and automatic testing at the patient's bedside. The device provides a visual indication of the pH detected at the tip of the gastric tube. The test result is given in binary form: Yes (green signal, probe in stomach) / No (red signal, probe incorrectly positioned). Study hypothesis and prospects: To make an initial estimate of the sensitivity and specificity of the NGPOD system for checking the positioning of the naso- or oro-gastric tube in the stomach, compared with the recognized gold standard, the chest X-ray.
The ADAPTAWORK_2 study is a follow-up to the first qualitative study, to evaluate the feelings of hospital workers in all occupations about teleworking. This involves measuring the variation between three periods: before the COVID-19 pandemic, during the first lockdown an after the pandemic. Secondary objectives were: 1) to evaluate wich factors were associated to the feelings towards teleworking, 2) to assess musculo-squeletal disorders among teleworkers and the other participants, 3) to assess psycho-social risks among teleworkers and the oher participants, and 4) to evaluate teleworking costs
Evaluate the efficacy of the test medical device (Pixie® skin tag) in the treatment of skin tags versus a comparator product (Wortie® skin tag remover).
Vitamin D plays an important role in phosphocalcic metabolism and bone homeostasis in newborns. Premature newborns are at risk of vitamin D deficiency and may require supplementation. In this context, the French Society of Pediatrics (Société Française de Pédiatrie) recommends systematic vitamin D testing at 1 month. The aim of this study was to determine the frequency of vitamin D deficiency in premature newborns.
In Western countries, one of the major nutritional challenges requires reducing the proportion of animal proteins and increasing the proportion of vegetable proteins in the daily plate. Added to this nutritional challenge is an environmental challenge, with plant proteins being much less expensive to produce. However, plant proteins are mainly provided by cereals and legumes, a large diversity of which is necessary to cover the recommended daily intake of amino acids. However, given the collapse of cultivated biodiversity (loss of 75% in 100 years, FAO), the diversity of the supply is very reduced. Furthermore, for several years, public health studies have indicated a chronic deficit in micronutrients (minerals/trace elements, vitamins, antioxidants) as well as fiber in the diet of the French population. This comes in particular from the impoverishment of the nutritional quality of the fruits/vegetables/cereals/legumes consumed. In general, diet plays a major role in the primary prevention of chronic diseases (cardiovascular, diabetes, cancer) including periodontal disease. Thus, a diet low in sugars, saturated fats and rich in fiber would reduce the appearance of periodontal disease by strengthening salivary capacity. However, certain pathogenic periodontal bacteria (such as Porphyromonas gingivalis) can migrate (blood, digestive or respiratory routes) to reach other organs and represent a risk factor for other chronic diseases. Thus, the prevention of periodontal diseases through diet control would also contribute to the prevention of other chronic diseases. The benefit of plant-based diets to reduce the risk of cancer is now established. In addition, certain cereals such as spelled have superior nutritional qualities to common wheat, notably their protein content and they also contain higher quantities of certain bioactive compounds with anti-cancer properties (such as phytosterols). Furthermore, the potential impact of the oral microbiota on chronic diseases is now being studied: in healthy adults, a dysbiotic periodontal microbiota may be likely to lead to systemic para-inflammation. It has also been shown that a dietary change (Mediterranean diet) could lead to a reduction in pathogenic bacteria in the oral microbiota (including P. gingivalis). However, the link between the introduction of cereals into the diet and the evolution of cancer risk factor bacteria in the oral microbiota has never been demonstrated. This pilot clinical study plans to focus on the oral microbiota, with the aim of objectivizing a possible link between a modification of the diet by the introduction of cereals (einkorn type) and the evolution of certain bacteria of this microbiota. , notably P. gingivalis (but also T. forsythia, S. anginosus, A. actinomycetemcomitans, T. denticola and F. nucleatum), considered as cancer risk factors and thus observe an improvement in health status oral and general.
PESTIFOL will include children over 8 and under 12 years old of different socioeconomic positions (SEP), mostly living in the region of Pays de la Loire. This approach should enable us to assess the impact of the SEP, and therefore social inequalities, on chemical expositions and DNA damage, and to characterize which (classes/mixture of) pollutants are major source of DNA damage. The study will also address potential effects associated with geographical location on the exposome and its biological consequences.
Primary and secondary brain tumors, the leading cause of death from cancer before the age of 35, represent a complex and heterogeneous group of pathologies with a generally poor prognosis. Knowledge of these tumors has made enormous strides thanks to access to biological samples, leading to a much more robust, reliable and precise histo-pronostic classification, but also, increasingly, to the identification of theranostic targets. Despite these advances, there is a real need to refine diagnostic and prognostic classification, identify the biological mechanisms involved in the formation and progression of these pathologies, develop new targeted strategies, and devise minimally invasive follow-up methods (liquid biopsies). In addition, certain non-tumoral brain lesions (e.g. malformations) can be similarly classified according to their molecular and mutational profile. This project aims to make a decisive contribution to these objectives.