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.
The ANRS ( Agence Nationale de Recherches sur le Sida et les Hépatites virales) 0093s Aging HAND study is to assess whether PLHIV (People Living with HIV) initially between 55-70 years of age at baseline analysis under antiretroviral therapy have accelerated decline of neurocognitive function after 6 years of follow-up. Aging HAND is a French, multicentric, longitudinal, transversal, prospective study with inclusion of 290 PLHIV.
Despite a clear indication of grade Ia, cardiac rehabilitation (CR) is dramatically underutilized after acute coronary syndrome with less than 30% of patients addressed in France. Mobile technology has the potential to overcome barriers to access to cardiac rehabilitation and may be a useful tool for increasing participation. However, studies have to prove this type of care is as effective as traditional center based cardiac rehabilitation.
The investigators have recently discovered a metabolic biomarker which predicts Parkinson's disease (PD) at the early stages in patients and in animal models. The aim of BIOPARK is to investigate how the biomarker evolves in advanced PD stage, when diagnosis confirmation is higher, an in de novo PD patients who come from a different geographical area than those of the publication (since it is known that the metabolome is largely influenced by lifestyle). They will also evaluate if the biomarker is able to distinguish patients with a parkinsonian syndrome often confused with parkinson's disease, i.e. Multiple System Atrophy (MSA).
Multicentric, prospective, opened study to evaluate the impact of Health Literacy Levels on CPAP withdrawal in Obstructive Sleep Apnea patients within 6 months of inclusion.
Vocal Folds scarring (whether congenitally or following phonosurgery) can result in a range of symptoms depending on severity and extent, such as hoarseness, breathy voice, increased effort to speak, and voice fatigue. The inability to phonate normally causes both physical and psychological disability, especially for professional communicators (teachers, tradesmen, singers, etc.). There are several therapies currently available but these are often disappointing, as the great complexity of vocal fold microstructure hinders the development of effective therapy. Thus, identification of innovative strategies able to improve vibrational mechanical properties of vocal folds remains an important clinical challenge. Autologous Adipose-Derived Stromal Vascular Fraction (ADSVF) is recognized as an easily accessible source of cells displaying angiogenic, anti-inflammatory, immunomodulatory and regenerative properties. Recent experimental and clinical reports also supported the anti-fibrotic potential of ADVSF, mainly attributed to the mesenchymal stem/stromal cell subset. Safety in humans has already been confirmed in several studies, including our previous clinical trial (ClinicalTrials.gov NCT0262246; EudraCT number: 2015-000238-31). The main objective of this phase I/II trial was to measure for the first time the safety and tolerability of autologous ADSVF local injections in patients with scarred vocal folds. No severe adverse events occurred: only some minor adverse events were reported. Moreover, Voice Handicap Index was improved in all patients with a mean improvement from baseline of 40.1/120 and seven patients were considered as responders, defined as an improvement ≥ 18 points. Based on these observations, we hypothesized that the injection of autologous ADSVF could reduce the process of fibrosis, improve vibration and then dysphonia and quality of life in patients with scarred vocal folds. In the absence of a reference treatment, the effectiveness of the ADSVF will be compared to a placebo: the local injection of excipients solution. This study will test efficacy of the autologous ADSVF to treat vocal folds scarring. It is a randomized, double-blind, phase II clinical trial conducted according to a 2-treatment parallel design, with medico-surgical and scientific collaboration. Recruitment and follow-up of patients will be done in 4 university hospitals by the respective ENT teams (Marseille, Toulouse, Nice and Montpellier): 36 patients will be recruited and treated on a 24 months period. At inclusion, 36 patients will be randomized (1:1 ratio) into two groups: ADSVF group and placebo group. Adipose tissue removal, ADSVF production and injection of ADSVF or placebo will be done on the same day during a short hospital stay. Patients will be followed and evaluated at 1 and 6 months with self-evaluation (Voice Handicap Index and a 10 points scale), video-laryngo-stroboscopic examination, vocal assessment with perceptive, acoustic and aerodynamic parameters and evaluation of adverse events. At the end of this 6-month follow-up (primary endpoint), patients of each group having tolerated the first injection well but in therapeutic failure (improvement of VHI <18 as described by Jacobson in 1997 or improvement of VHI ≥ 18 but not normal which means > 20 according to Woisard, 2004) will be offered an injection of thawed and washed ADSVF. Patients will continue to be followed in open-label on the same endpoints.
This is a multicenter, interventional, non-randomized study among patients with a relapsed or refractory Wilms tumor. The study will aim to assess efficacy of metronomic chemotherapy, in terms of disease control after two cycles of metronomic chemotherapy.
The patient is seen upstream by an anaesthetists resuscitator (MAR) in order to carry out his anesthesia consultation. If the patient meets the eligibility criteria he will be informed of the study and his signed consent will be obtained. Patients will be divided into 3 parallel groups : - Group A (placebo +remifentanil) - Group B (sufentanil + placebo) - Group C (placebo + placebo) Constants are taken at T0. A non-invasive continuous monitoring (Clearsight ©) will be used to collect data: blood pressure, heart rate, cardiac output. To ensure double-blinding the nurse who prepares the syringes is not part of the anesthesia team. He/she numbers them in syringe n°1 and n°2 to indicate the order of injection to the MAR. The MAR injects the drugs according to the standardized study plan (see below): - T1: the patient receives an intravenous bolus (IV) over 5 seconds of molecule n°1 - 3 minute delay - Patient receives Etomidate 0.3 mg/kg IV over 10 seconds - 5 second delay - The patient receives an IV bolus over 30 seconds of molecule n°2 - 5 second delay - The patient receives Succinylcholine or Rocuronium IV over 5 seconds - T2: End of induction, oro-tracheal intubation (= T2) The laryngoscopy is performed by an experienced MAR or nurse (IADE). The end of the intubation is defined by the fixation of the intubation tube (T3). Hemodynamic parameters are measured every minute for ten minutes after intubation (T4 to T13). Maintenance of anesthesia is standardized with halogen gas (SEVOFLURANE) and an opioid (SUFENTANIL). Ten minutes after the patient's intubation (T13), the blind is lifted, allowing the addition of sufentanil in groups A and C before any surgical procedure.
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-655, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will evaluate the overall safety and tolerability of NVL-655 and will determine the RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-655 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors.
Aortic stenosis (AS) is the most frequent valvulopathy in the general population in France and more generally in developed countries, due to populations aging. Its standard treatment is historically surgical aortic valve replacement (SAVR). In the 2000s, the management of this valvulopathy was revolutionized by the development of the technique of per-cutaneous aortic valve replacement (TAVI). TAVI opens the possibility of curative treatment to patients at high operational risk not operable by conventional surgery, and for whom outcome was affected with high mortality under medical treatment alone. Amyloidosis, a pathology with multiple etiologies, is a rare condition and its cardiac form (AC) even more (8 to 17 / 100,000 people / year). However, its prevalence is increasing. Some autopsies series have found prevalence up to 50% of cardiac amyloidosis with transthyretin (AC-TTR) after 60 years. In addition, recent data suggested that AC-TTR prevalence is higher in the population of patients with heart disease: 13% in heart failure with preserved ejection fraction and up to 16% in patients with AS. The outcome of patients with AC-TTR remains unknown after TAVI. Thus, the diagnosis of AC-TTR in patients undergoing TAVI represents an important issue. Indeed, a treatment stabilizing the process of accumulation of transthyretin deposits, effective on the survival of these patients, is now available. In addition, a non-invasive screening strategy for AC-TTR, alternative to biopsy, is now validated.
Psychosis is a severe, common, and disabling psychological disorder. An epidemiological study conducted in England reported an incidence of 34 new cases per 100,000 person-years, with a peak between 16 and 19 years of age. Following a first psychotic episode, two clinical evolutions are possible: thymic psychosis (17%) and non thymic psychosis (83%). The first includes bipolar disorders with a psychotic component and major depressive disorders with a psychotic component; the second, other psychotic disorders, mainly schizophrenia. One of the major difficulties encountered is the frequent impossibility of specifying the type of psychosis at the beginning of the psychotic episode. However, these disorders require different therapies, particularly medication. This leads to a delay in diagnosis with a high risk of relapse. The semiological study of these diseases being carried out within the framework of interviews, it seems interesting to be able to record these and to obtain a quantitative and objective measurement through the study of language. The use of machine learning has made it possible to distinguish patients with schizophrenia from those with bipolar disorder by graphical analysis of language in a more efficient way than with clinical scales.Moreover, it is possible to identify linguistic markers: thus, an alteration of syntactic structures and prosody would be more present in non-thymic than in thymic psychoses. Paraclinical markers are also emerging. In particular, the link between inflammation and mental disorders.For example, an increase in IL-8 has been found only in thymic psychoses. At the radiological level, distinct changes in the volume of grey matter have been shown between thymic and nonthymic psychoses. In this context, it seems essential to be able to distinguish these disorders as early as possible through the combined use of clinical and paraclinical markers, and to be able to better understand their pathophysiology.