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.
Prevalence of PAD and osteoporosis (OP) both get higher with age. Clinical and epidemiologic evidence have showed an increased cardiovascular risk in OP and bone loss and fragility fractures in patient with cardiovascular disease. This study will examine the relationship between vascular disease in legs and sBMD and vBMD at trabecular and cortical sites and bone microarchitecture.
The aim is to study another alternative for the treatment of pain in people with CRPS. Indeed, the TRAB / Medullary occupational therapy department of the CMRRF in Kerpape used compression garments to reduce edema when it was present.In the case of CRPS of the upper limbs, gloves or compression sleeves are used to decrease the edema which is sometimes associated, although they are not supported for this indication. In this context, our clinical experience leads us to believe that there would also be some efficacy in neuropathic pain, this improvement being regularly described by patients.This study is expected to show a notable reduction in neuropathic pain thanks to the wearing of a compression garment.
Inherited movement disorders are rare conditions, whose cumulative prevalence are in the order of 5-10/100,000 inhabitants, in most cases progressive and can lead to a significant loss of autonomy after one or more decades of evolution. They include spinocerebellar ataxias and hyperkinetic disorders (dystonias, choreas, tremor, parkinsonism and myoclonus with variable combination of those, or more complex alteration of movements). The existence of the National Reference Centre (CMR) for Rare Diseases (CMR Neurogenetics, devoted to ataxias and spastic paraparesis, dystonia and rare movement disorders and CMR Huntington, devoted to Huntington Disease) has allowed a more integrated vision of these diseases. This is illustrated, in the same family, by the occurrence of different clinical expressions of spinocerebellar ataxias and hyperkinetic disorders that share the same genetic background. Conversely, different causal mutations within the same gene may have very different ages at onset and a wide range of clinical expression, and the spectrum of new phenotypes linked to a single gene is still expanding . Many ataxia and dystonia genes are involved in similar pathways. There are numerous arguments supporting a share pathogenesis including synaptic transmission and neurodevelopment . BIOMOV project aims to : 1. establish the clinical spectrum and natural history of these diseases, 2. understand the role of genetic and familial factors on the phenotype, 3. elucidate the molecular basis of these disorders and evaluate diagnostic strategies involving molecular tools for clinical and genetic management, 4. develop multimodal biomarkers both for physiopathological studies and for accurate measures of disease progression, 5. develop trial ready cohorts of well characterized genetic patients, 6. test new therapies either symptomatic or based on pathophysiological mechanisms.
This study is for women in menopause who have moderate to severe hot flashes. It is for women who are unable to use hormone replacement therapy (HRT). Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life. The study medicines (also called investigational products, or IP) are tablets of fezolinetant or placebo. An investigational product means that the product is not yet licensed. In this study, a placebo is a dummy treatment that looks like fezolinetant but does not have any medicine in it. The study will compare fezolinetant with the placebo to learn if fezolinetant reduces the number and severity of hot flashes. Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes. Some women may be able to use the app on their own smartphone. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. Women will be picked for 1 of 2 treatments (fezolinetant or placebo) by chance alone. Women who take part in the study will take 2 tablets every day for 24 weeks. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study medicines (fezolinetant or placebo). The women will continue recording information about their hot flashes on the electronic device or their phone. They will also use another device to answer questions about how hot flashes affect their daily life. During the study, the women will visit their study clinic several times for a check-up. This will happen during Weeks 2, 4, 8, 12, 16, 20, 24, and 27. Some women may be able to have home visits instead, from Week 2 to Week 20. At the check-up, they will be asked if they have any medical problems. Other checks will include vital signs (heart rate, temperature and blood pressure) and some blood samples taken for laboratory tests. At some check-ups, the women will have a physical exam. In Week 2 and Week 24, the women will have an ECG to check their heart rhythm. Women who have a uterus will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs. The last check-up (at Week 27) will be 3 weeks after they take their last tablets of study medicine (fezolinetant or placebo).
Multiple Sclerosis (MS) is a demyelinating auto immune disease of the central nervous system, affecting 2500000 people worldwide. Risk factors for MS severity are not yet well-known , but previous studies highlighted that relapse rate increased during influenzae epidemics, and air pollution could be a risk factor for MS relapses. MS is a neurological chronic disease that requires constant medical treatment and regular rehabilitation care. COVID-19 pandemic and restrictive measures taken to limit contaminations have drastically decreased air pollution and seasonal viral infections exposure, but sanitary crisis also limited care access for MS patients (medical treatment, rehabilitation). Therefore, this particular period offers a unique opportunity to evaluate the impact of air pollution, viral infections, and health care access on the severity of MS. The main objective is to evaluate the impact of air pollution and seasonal viral infections on the risk of MS relapse, using the year 2020 as a quasi-experimental model. The secondary objective will be to evaluate the impact of health care access limitations on the risk of neurological disability accumulation. This study will include 1500 MS patients, living in Ile de France, followed in the neurological department of "Pitié-Salpêtrière" Hospital. This is a retrospective observational study nested in OFSEP registry (French Multiple Sclerosis Observatory), which is a prospective cohort of MS patients in France. Air pollution data will come from AIRPARIF, and viral infections data will come from "Santé Publique France". A better knowledge of the impact of air pollution, viral infections, and health care access on the course of MS will enable to better guide information to patients and public health care decisions.
Kidney disease in its chronic or acute form shares many risk factors for initiation, progression and prognosis with an increase in morbidity and mortality, the length of hospitalization and the cost associated with stages of increasing severity. Its overall estimated prevalence in the general population is 13% and 0.5% from stage 4, for which referral to a nephrologist is recommended to reduce mortality, slow progression of renal disease and better prepare for treatment by renal replacement. Acute kidney injury (AKI) is defined as a sudden increase in serum creatinine (Scr) with a prognostic classification of increasing severity. The population with chronic kidney disease (CKD) is often hospitalized and is frequently complicated by AKI, however CKD is asymptomatic for a long time, requiring structure screening in populations at risk. Performing Scr assays during hospitalization is an opportunity to screen patients with severe CRD or ARI requiring specialized treatment during and after hospitalization. A nephrological opinion is recommended for patients with severe CKD and AKI. Based on preliminary studies "MRC GARD" (NCT02938611) and "ARI TARGET" (NCT03192189), the study investigators identified the frequency of patients with increased Scr corresponding to stages ≥4 of CKD and to stage1b of ARI during their hospitalization. They found that 50% of patients hospitalized with a severe AKI had a CKD prior to their hospitalization. The use of dosages of Scr during hospitalization has been studied for AKI but without targeting high-risk subgroups and with discordant results. The study investigators plan to carry out a pragmatic study to show that an intervention combining alerts with Scr dosage to detect severe forms of CRD and AKI during hospitalization associated with the systematic intervention of a specialized dedicated team associating nephrologist and pharmacist to the scale of a GHT will improve patient and renal survival 1 year after screening.
The COVID-19 outbreak has been categorized as a pandemic and declared an international public health emergency by WHO. In this context, an exceptional mobilization and a complete reorganization of the organization of the healthcare offer was put in place.The investigators will study the psychological consequences among emergency department (ED) / SAMU (Service d'Aide Médicale Urgente) professionals exposed during the COVID-19 pandemic to high psychological stress due to work overload, changes in practices and fears of contamination.They will evaluate at 9 and 12 months after the end of the second lockdown (July December 2020), post-traumatic stress disorder (PTSD), personal and professional stress, anxiety and depression, burn-out and consumption of anxiolytic products. This is a multi-center study and includes doctors, DE interns and nurses, other paramedics and medical regulatory assistants working in one of the ED or SAMU working during phase 3 of the COVID-19 pandemic. It should make it possible to know the psychological load of the months following the epidemic among health professionals who worked in emergencies during this period and to understand their risk of occurrence of PTSD. These elements are also essential to improve the management of health crises and to put in place preventive measures for health professionals, in particular in anticipation of recurrences, second wave or future new episode.
The Covid-19 pandemic is having a great impact on the long-term mental health and well-being. Reports on the levels of psychological distress are concerning. This can be due to the pandemic, as well as social distancing, employment and economic consequences. Healthcare workers, the elderly, youths, and persons experiencing socio-economic adversity are at risk of developing psychological distress. In this context, healthcare systems risk being overcharged, facing a growing demand. Cognitive Behaviour Therapies managing psychological distress have been formally recommended. WHO has implemented different escalated psychosocial interventions, such as Problem Management Plus, PM+; Doing What Matters in Times of Stress, DWM; and Psychological First Aid, PFA. Their aim is to help individuals manage their stress in order to decrease the occurrence of psychological problems. They do not replace care for severe mental health disorders, but can prevent the deterioration of individuals' mental health. PM+ has previously been found to be effective in situations of endemic conflict or violence in Pakistan and Kenya. The implementation of this program in Europe is being evaluated in the EU H2020 project STRENGHTS, focused in migrants from Syria. In the present trail, the investigators aim to further test its effectiveness in the context of psychological distress resulting from the COVID-19 pandemic. Prior to the present trial, the investigators conducted a qualitative research study among potential beneficiaries and healthcare workers to evaluate the feasibility of DWM and PM+, which showed interest in stepped-care interventions in mental health, particularly if they are technology-based (mobile phones). Our study is embedded in the larger, EU H2020 CORONAVIRUS-funded RESPOND project (Grant Agreement No 101016127). This project granted funding for a multicentric, single-blinded, randomised, controlled trial to evaluate the effectiveness of the stepped-care DWM and PM+ program vs. Care as Usual (CAU). In France, the investigators will focus on persons experiencing socioeconomic adversity, as defined by unstable housing conditions. A recent study showed that most of them are migrants. All subjects (210) will receive PFA and CAU. In addition to PFA and CAU, the treatment group (105 subjects) will receive the intervention DWM (with or without PM+). The primary outcome will be the decrease in symptoms of anxiety and depression from baseline to two-months follow-up.
The management of a patient with shock is based on improving tissue oxygenation through hemodynamic optimization. Lactate is a marker of tissue hypoperfusion commonly used in the ICU. In principle, hyperlactatemia can be caused by either increased tissue production (tissue hypoperfusion: type A), decreased lactate uptake (type B), or a combination of both mechanisms. It is important to correctly determine the cause(s) of hyperlactatemia, as this determines the treatment (expanders, inotrope, vasopressor, blood derivative transfusion), and the patient's morbidity and mortality. A classic example of this concept is volume expanders, which are frequently used to correct hyperlactatemia secondary to tissue hypoperfusion, but are associated with mortality if used excessively (fluid overload). In clinical practice, it is difficult to differentiate the exact causes of hyperlactatemia (type A and type B). From work carried out over the last 20 years in septic shock and then in other states of shock and in the operating theatre, it has been shown that the arteriovenous CO2 gradient (pCO2gap) measured from arterial and venous blood gases is a marker of tissue hypoperfusion with better predictive ability than the usual markers (clinical examination, SVO2....). Furthermore, when we relate pCO2gap to the arteriovenous O2 difference (pCO2gap /C(a-v)O2), this ratio allows us to distinguish with greater accuracy between states of acute circulatory failure associated with anaerobiosis (tissue hypoperfusion, type A) and those related to the underlying disease. Also, several studies have demonstrated a strong ability of the pCO2gap and the pCO2gap/CavO2 ratio to predict the severity of shock, mortality of the shock patient, hyperlactatemia, and correction of hyperlactatemia with hemodynamic treatment. As a result, many authors have proposed algorithms for the management of shock patients based on the measurement of these CO2-derived indexes. The hypothesis of this study is that the use of an algorithm based on CO2gap and the CO2gap/CavO2 ratio is superior in terms of correction of hyperlactatemia to usual practice based on clinical and macro-hemodynamics.
The purpose of this study is to assess the efficacy of Xylocaine impregnated compress in reducing per-procedural pain during ultrasound-guided infiltration of Trigger Finger