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.
Medication-related osteonecrosis of the jaw (MRONJ) occurs after taking bisphosphonates or targeted therapies. It leads to a significant decrease in quality of life with pain, eating and chewing disorders, and malnutrition. Current treatments are only partially effective. PENTO (pentoxifylline and tocopherol) has been shown to be effective in maxillary osteoradionecrosis. The objective of this study is to evaluate the proportion of bone recovery in patients receiving PENTO in MRONJ at 12 months.
Peripherial arterial disease (PAD) and diabetes are major public health issues. In 2020, according to the latest epidemiological data, it is estimated that there will be more than one million patients with PAD and more than 3.5 million diabetic patients in France. In the diabetic patient, screening for PAD is carried out by calculating the Toe-Brachial pressure index (TBi), a technique that remains time-consuming and technically demanding, which limits its use for clinical routine screening. A new photoplethysmographic method (PPG) makes possible to determine the quality of peripheral perfusion thanks to the automatic computation of the upstroke time (TMS in ms). This method appears to be a promising, inexpensive, faster and easier technical alternative to improve the dissemination of the vascular screening in diabetics. To date, no prospective study has established a relationship between the measurement of upstroke time using the PPG method and TBi in a specific diabetic population.We will perform a two-centre prospective study (Nice University Hospital and Antibes Hospital) comparing the two techniques. The main objective of our study will compare the values of the upstroke time obtained by a PPG method and the TBi in a population of diabetic patients. The secondary objectives will be to compare the TBi values to the ratio of the TMS measurements at the toe to the reference TMS measured at the hand and to determine the sensitivity-specificity of the TMS measured by PPG compared to the TBi in the detection of a significant PAD in diabetics.
Post-extubation dysphagia (PED) is a frequent but still underestimated condition in the intensive care units (ICU). In the international literature, the manifestations and consequences of PED lead to intra- and post-intensive care comorbidities. The exact etiology of PED is unknown, but considered multifactorial. Numerous causes, acquired during ICU, can lead to a delay in the reintroduction of intravenous nutrition, or even favor the development of inhalation pneumopathy. One of these causes is the presence of the nasogastric tube. The incidence of ECD varies from 3 to 62%. Its presence impacts morbidity and mortality. Preventive strategies for PED have only been studied with questionable methodologies. The goal of ICU therapists is to detect PED as early as possible in order to implement curative strategies such as adapted nutrition and early swallowing rehabilitation.
The primary objective of the study is to rule out an increase of >3mmHg in 24-hour average Systolic Blood Pressure at steady state (Week 4) compared to baseline. ABPM was chosen for the blood pressure assessment in this trial as recommended by the FDA for drugs intended for chronic use (Assessment of Pressor Effects of Drugs Guidance for Industry (FDA 2022)).
Post-thrombotic syndrome (PTS) is the most frequently observed chronic complication of deep vein thrombosis (DVT), with an estimated cumulative incidence of 20-50%. Endovascular venous recanalization with angioplasty and stenting of obstructive lesions is the recommended treatment option to reduce or correct the symptoms of DVT. However, its impact on the physical capacity and breathlessness of patients has not been fully demonstrated. The heterogeneous evidences of clinical improvement is probably related to the presence or absence of collateral veins developed in these patients with proximal venous obstruction (iliac or iliofemoral with or without inferior vena cava involvement), which ensure the cardiac venous return. The aim of this study is to compare changes in maximal oxygen uptake after endovascular venous recanalization in DVT patients and to evaluate the hemodynamic, respiratory and muscular improvement induced by the restoration of venous flow in the occluded segments.
Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: - take blood and urine samples. - measure PSA and testosterone levels in the blood samples - do physical examinations - check the participants' overall health - examine heart health using electrocardiogram (ECG) - check vital signs - check cancer status using PSMA PET/CT scans, CT, MRI and bone scans - take tumor samples (if required) - ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first.
The goal of this interventional study is twofold with the evaluation of the feasibility and potential usefulness of an implementation strategy, and the efficiency of a community-based model of mass screening and immediate treatment of hepatitis C among People Who Use Drugs (PWUD) in three major cities in mainland France (Paris, Lyon and Marseille) and in one overseas city (Fort-de-France). The investigators will also describe the psychological and infectious comorbidities of drug users, determine the stages of the HCV (Hepatitis C Virus), HBV (Hepatitis B Virus), HIV (Human Immunodeficiency Virus) care cascade, and analyze the factors associated with HCV treatment failure. A qualitative study will investigate the acceptability of the RDS model. Participants will be screened in an out of bound research center and receive appropriate treatment for infectious, addictological and psychiatric troubles. They will receive coupons to give to their peers for them to participate in the study. Researchers will also compare the acceptability of referral to psychiatric care directly at the research site (intervention group) with that of referral directly to a city facility (control group).
Hepatic (hepatocellular carcinoma (HCC)) and pancreatic (pancreatic adenocarcinoma (ADKP); pancreatic neuroendocrine tumors (TNEP)) primary tumors are the most common malignant tumors of the hepato-bilio-pancreatic system and represent a major public health issue. At present, the management of these tumors is based on recommendations based on the existence of rudimentary prognostic and theranostics markers that do not sufficiently accurately reflect the heterogeneity of tumor biology. It therefore seems essential to identify new and more relevant markers in order to optimize the care of these patients in daily practice. Metabolic reprogramming is now recognized as an essential feature of cancer cells, allowing them to fuel and maintain their proliferation and tumor growth. Such metabolic reprogramming requires modification of several energy pathways, the most commonly recognized being the transition from energy metabolism based on oxidative phosphorylation to energy metabolism based on glycolysis, even under aerobic conditions (Warburg effect). In this context, the investigators hypothesized that the consumption of nutrients by the tumor cell differs significantly from that of the normal cell in order to support its increased energy needs, and that this important and specific metabolic reprogramming would be correlated with the histo-prognostic and theranostics factors of these tumors. Preliminary analyses on surgical resection parts conducted by the various partners in 2019 made it possible to characterize the metabolic signatures of a series of HCC and ADKP resected using the Metafora biosystems technology platform. These signatures reflect a metabolic program characteristic of these tumors, which reveal strong specificities. Similarly, a candidate signature correlating with the presence of vascular microscopic invasion has been identified in HCC, and the level of activation of glycolysis and glutaminolysis by certain ADKP cells also appears as a trait of interest vis-à-vis the aggressiveness of this cancer. Thus, the current project will aim to confirm the feasibility of identifying specific prognostic and theranostics metabolic signatures early, on biopsy samples and / or circulating blood cells.
Non-melanoma skin cancer (NMSC) incidence as well as morbidity rates are high in older patients. Surgery is the standard of care. About 5 to 10% of NMSC present high-risk clinico-pathologic features that can increase risk of local recurrence (LR). Adjuvant radiation therapy (ART) is often discussed regarding the risk of local recurrence. Despite the lack of high level evidence, ART is indicated in patients according to unfavorable prognostic factors. ART benefit is generally questioned in regard to the potential degradation of the patient's quality of life (QoL). Currently there is no prospective trial or recommendations that take into account geriatric patients' evaluation and profiles during the management of NMSC. In addition, there is no data that could help to define the subgroup of elderly patients who will benefit from ART in tumors with unfavorable prognostic factors. In terms of ART, multiple fractionation schedules are available, ranging from standard fractionation (45-60Gy in 5-6 weeks) to the extreme hypofractionation (HF) delivering 16-18Gy in one fraction. In routine practice, HF is mainly preferred in elderly patients for more convenience by reducing the number of transports and increase health related quality of life (HRQoL). However, there is no data on the fragility profiles of these patients, nor validating any HF schedule in terms of efficacy, acute toxicity, cosmetic results, and impact on HRQoL. the main ain objective is to evaluate the comparative efficacy of two modalities of Radiotherapy over surgery alone on local tumor control in older patients with Non Melanoma Skin Cancer (NMSC) In current practice, adjuvant radiotherapy is discussed regarding the risk of local recurrence as determined by the existence (or not) of unfavorable prognostic factors. The proposed study will include R0-high risk of CBC and CEC of the skin in elderly patients. There is no risk regarding the design of the trial as the last will respond to two important unknown questions regarding the utility of RT and its fractionation in this population. Moreover, it is an excellent opportunity to collect prospectively geriatric evaluation and HRQoL data that are lacking in the literature for skin cancers. No constraints are seen neither in the design, nor in the potential recruitments.
ST-segment elevation myocardial infarction (STEMI) is an acute condition that accounts for 75% of sudden deaths in adults over 35 years of age and more than half of all cases of chronic heart failure. However, the mechanism of myocardial infarction remains poorly understood. At present, there is no national information system for myocardial infarction, as there is for other diseases such as multiple sclerosis (OFSEP cohort). The purpose of this cohort is to enable studies and research projects to be carried out on the descriptive epidemiology of myocardial infarction, monitoring of patients undergoing treatment (safety, efficacy), quality of life and functional consequences of infarction, and research into new biological and imaging prognostic biomarkers. Its general objective is to provide researchers, hospital practitioners, medical interns, academics or industrialists with a quality epidemiological tool for research.