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.
Sepsis is a constant concern in ICU, frequent and severe, it requires early diagnosis and prompt implementation of the etiological treatment. The bacterial infections are the most common and are associated with high morbidity and mortality. Diagnosis is based on the detection of micro-organisms (bacteria) that can confirm the diagnosis and to tailor antibiotic treatments. Blood cultures are positive in 30-35% of cases and diagnosis is often based on a body of evidence that the use of biomarkers. No biomarkers (or even a combination of biomarkers) no evidence to confirm or refute the diagnosis of sepsis alone. During sepsis, gram + and gram - are circulating and often present in small amounts; they can be detected by sensitive and specific tools following a pretreatment of the blood sample (innovative technology Bacti-DIAG). The main objective of the multicentre study Bacti-DIAG-Rea is testing in prospectively, in a suspicious population resuscitation of sepsis, this new bacterial biomarker. Secondary objectives will assess whether Bacti-DIAG provides time and precision gain (gram + vs grams) in the patient's care including diagnosis and treatment. All ICU patients and with clinical criteria of Systemic Inflammatory Response Syndrome (SIRS) sepsis suspects will be included: in addition to the samples taken for routine care of the patient 4 tubes of whole blood will be collected 5mL. The definitive diagnosis of sepsis or SIRS be confirmed retrospectively by two independent experts blinded to Bacti-DIAG. The areas under the ROC curves for the detection of gram + and gram will be calculated and associated detection limits will be determined to meet the objectives of the study. It is planned to include 400 consecutive patients with SIRS criteria for sepsis 300-360 and analyze biometric and biological data based on the subsequent evolution of the patients. The care of patients will be blinded to the results of the new biomarker Bacti-DIAG
The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery. Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months. This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection. The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.
The nanoparticles (NP) are defined as particles whose size is no greater than 100 nanometers. However, their impact on health remains little evaluated. Placental transfer of NP has been proven in many studies in vitro and in vivo in animals, and toxicity in the fetus has been studied in many animals. The investigators seem interesting at first to establish the mineralogical load in the amniotic fluid in humans. The first objective of this study is to determine the mineralogical NP load, quantity and composition, in the amniotic fluid in pregnant women.
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
Clinical study, comparative, prospective, interventional, randomized, single-center, single-blind The fast resumption of the walking after surgery of total prosthesis of hip (PTH) requires an effective analgesia from the immediate post-operative period. In France, whatever is the peroperative anesthesia, the analgesic reference technique is a locoregional anesthesia (ALR) ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh. In the Anglo-Saxon countries, in particular in Australia and in the United States, the techniques of peroperative infiltration of local anesthetics (IAL) by the surgeon supplanted the techniques of traditional ALR. However, no French study compares the IAL with the conventional ALR with a rigorous methodology. Our occasional practice of IAL suggests us that it is more effective in terms of post-operative analgesia with Analog Visual Scales decreased (EVA) and a lesser consumption of morphine. Furthermore, the resumption of the upright posture in bipedal support as well as the resumption of the walking would be earlier. The main objective is to show that the post-operative analgesia by local peroperative infiltration is superior to that obtained by locoregional anesthesia (ALR by femoral block associated with a side cutaneous block of the thigh) after the surgery of total prosthesis of hip, with decrease of the consumption of morphine within first 72 post-operative hours. The secondary objectives are to compare the Analog Visual Scales of pain (EVA) with the rest and with the mobilization during various times (in post-surgery care room, then at H4, H8, H12, H24, H48, H72), the period between the end of intervention (out of the operating room) and the first support by the upright posture in bipedal support), the period between the end of intervention and the resumption of the walk, the satisfaction of the patients at the exit of the hospital, the duration of hospitalization after the surgical operation and the possible unwanted events (systematic toxicity of the local anesthetics, the infection of prosthesis, disease thromboembolic venous) during the hospitalization.
Persistent insomnia has a high prevalence in French general population affecting between 15.8 % and 19 % of adults. In France, the disease is mainly managed by general practitioners (GP) who usually proposed intermediate half-life benzodiazepines and Z-drugs in first-line treatment. French Health authorities recommend restricting the consumption of both hypnotics to no more than 4 weeks, considering their potential adverse effects (memory impairment, altered sleep physiology, motor-vehicle crash), and the risk of tolerance and dependence. However, it appears that a majority of patients become chronic users. Therefore, discontinuation of benzodiazepines/Z-drugs is recommended, but it may appear as a challenge due to withdrawal symptoms and psychological factors (anticipatory anxiety, fear of rebound insomnia). Numerous studies have shown that programs based on Cognitive-Behavioural Therapy (CBT) principles improve sleep and daily life quality leading to hypnotic taper and maintain of hypnotic abstinence in insomniac patients. Cognitive-Behavioural Therapy (CBT) is based on 4 components: sleep restriction, stimulus control, cognitive therapy and sleep hygiene education. This therapy is dependent on a therapeutic alliance between practitioner and patient. Unfortunately, there are an insufficient number of trained CBT experts especially in France. The implementation of an internet-delivered self-help program based on time-in-bed restriction and stimulus control may be an issue within the context of general practice. Online programs based on CBT principles have been proved to be effective in improving the sleep and daytime functioning in this population, but the studies were realized in small patients groups. Investigators hypothesis is that a simple and internet-delivered short-term program based on sleep restriction therapy and stimulus control (following to a GP consultation) may facilitate hypnotics discontinuation (benzodiazepines/Z-drugs) in patient with insomnia disorder still reporting sleep complaints in comparison with a tapering alone (no access to the self-help program).
The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.
Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers
The goal of clinical trial is to evaluate the effect of one month of consumption of mineral water rich in magnesium or not on perceived stress, duration and quality of sleep in healthy consumers having magnesium daily intakes below the recommended dietary allowance (RDA).
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.