There are about 92 clinical studies being (or have been) conducted in Monaco. 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.
COVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death. In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue. HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method. Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).
Objective of SepSIGN project is to validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department. Targeted population is adult patients, freshly admitted at ED, with a suspected or confirmed infection.
Brain injury is a frequent purpose for consultation in emergency services. Management of brain injury is time and resource consuming, combining clinical monitoring and imaging. The stage prior to the management of the victims of brain injury is stratification of the severity, potential or proven. Severe brain injury requires emergent brain CT-scan, ideally within one hour of the first medical contact. Patients requiring this strategy present with focused neurological deficit, Glasgow score <15 to 2 hours after the trauma, suspicion of open fracture of the skull or dish pan fracture, any signs of fracture of the skull base (hemotympanum, bilateral peri-orbital ecchymosis), otorrhea or rhinorrhea of cerebrospinal fluid, more than one episode of vomiting in adults, and posttraumatic convulsion. Patients benefiting from anticoagulant therapy are included in this category. Victims of brain injury that do not fall into this category are considered less critical. By definition, mild traumatic brain injury : - a trauma of the cephalic extremity : - whose Glasgow score (30 min after the trauma or during the consultation) is 13-15, - associated with one or more of the following: confusion; disorientation; loss of consciousness of 30 min or less; post-traumatic amnesia of less than 24 hours; other transient neurological abnormalities (focal signs, epileptic seizures, non-surgical intracranial lesion). Among these patients, some are considered at risk of developing intracerebral lesions. Nevertheless, it should be noted that the prevalence of hemorrhagic complications is radically different between patients with a Glasgow score of 13 and those with a score of 15. Thus, the recommendations suggest a brain scan without injection of contrast media within 4 to 8 hours for patients with the following characteristics : - a retrograde amnesia of more than 30 minutes, - a loss of consciousness or amnesia associated with: - either a risk mechanism (pedestrian overturned by a motor vehicle, ejection of a vehicle, falling by more than one meter), - or an age> 65 years, - or coagulation disorders, including the use of platelet aggregation therapy. Patients who fall outside this definition are considered low risk of complication and should not benefit of imaging. Data from the scientific literature show that an early brain CT-scan allows identification of post-traumatic lesions in this population. Nevertheless, organizational problems, including the availability of the imaging, radiation, and disruption of surveillance related to patient displacement, are limitations to this strategy. In contrast, the low cost-effectiveness of CT scan is often advocated in patients with mild traumatic brain injury. For example, in the Octopus study, 52 of 1316 patients who received CT scan after mild head trauma had an intracerebral lesion. Among these patients, 39 (3%) had intracerebral lesion related to trauma; for 13 (1%) patients, the link with the trauma was uncertain. In fact, the search of alternatives for a safer, more conservative, more efficient practice, one of the objectives of which is to limit the undue use of cerebral scanning. Thus, many teams have been interested in the use of biological variables to guide the decision to use imagery. Among candidate biomarkers, the S100B protein has been the subject of many evaluations which allow it to be used in current practice. Indeed, the increase of the S100B protein carried out within 3 hours following a mild head trauma makes it possible to identify the patients at risk of intracerebral lesion and to target the indications of imaging. The purpose of the registry is to describe the use, interpretation and performance of the S100B protein in its use at bedside in emergency medicine.
Biological markers of depressive states have been studied, but their usefulness to predict the therapeutic response is unknown. This issue is major in all depressive states which have not remitted after several lines of treatment. rTMS (repetitive transcranial magnetic stimulation) is a non-pharmacological alternative in the treatment of depression, but its effects on cerebral functioning are not known in episodes which have resist to conventional treatments. The investigators will include 50 depressive patients who have failed to respond to two successive antidepressant medication, and propose them a treatment with low frequency rTMS during 3 to 6 weeks. Cerebral functional imaging with 18FDG-PET (positon emission tomography) with be assessed at the beginning and at the end of rTMS acute treatment, in order to measure induced metabolic changes and their correlation with clinical states. Patients who have responded to rTMS acute treatment may continue this therapeutic for six months, and the investigators will assess if efficacy maintenance is related with cerebral metabolic variations
This project aims to provide the proof of concept for transcranial direct-current stimulation (tDCS) in the treatment of resistant/persistent Schizophrenia symptoms. The purpose is to investigate the effect of tDCS on symptoms in schizophrenic patients demonstrating a partial response to a first frequently prescribed antipsychotic medication. An early optimization of the therapeutic strategy must constitute an important factor for prognosis. Hypothesize is that tDCS should alleviate symptoms in patients depending on the clinical characteristics. In this study, stimulation is an add-on treatment to antipsychotic medication, and will be used in a broad variety of patients, i.e. in patients with varied durations of illness, various symptoms profiles, and various levels of treatment response. This in turn will allow the determination of the extent to which results can be generalized to varied patient populations, as well as the extent to which various therapeutic targets (e.g. different symptom dimensions, cognitive performance and brain connectivity) may be improved with tDCS. Despite interesting preliminary results, our team is unable to describe optimal non-invasive brain stimulation (NIBS) response markers. This study is a randomized, double blind, controlled, French multicenter study (11 centers). The investigators plan to include 144 patients with persistent symptoms in schizophrenia. Seventy two subjects will receive active tDCS and 72 subjects will receive sham tDCS (placebo). Hypothesize is a lasting effect of active tDCS on the schizophrenic symptoms as measured by the number of responders, defined as a decrease of at least 25% of symptoms as measured by a standardized clinical scale score (PANSS) between baseline and after the 10-session tDCS regimen. Furthermore, the participants believe that an in depth understanding of the cortical effects of tDCS could constitute an important step towards improving the technique and developing treatment response markers. An analysis of the effects on cortical activity and plasticity markers could be an interesting approach.
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
No prospective study was conducted in elderly patients with cancer to assess the relative value of disease-related and patient-related prognosis factors. Patient-related prognostic factors have been highlighted in elderly patients with cancer resulting in the necessity of a geriatric assessment. The impact on overall survival of all of these factors was recognized in elderly people with cancer but remains unknown in High Risk Myelodysplastic Syndromes (HR-MDS). Therefore this information could be crucial to better select geriatric assessment domains relevant for the prediction and to recommend simplified tool after stratification of geriatric assessment domains thanks to their predictive value. The main hypothesis is that patient-related factors will have a better capacity to predict survival and treatment tolerance than disease-related factors in HR-MDS aged 75 and over and that the predictive value will be different among assessment tools which allows a selection of reduced number of tools for clinical use. To best knowledge estimation of predictive value of geriatric assessment tools remains unknown and explains why no standardization of practice exists. In testing all tools at the same cohort of patients allows to compare different tools and to define minimal and optimal geriatric assessment for HR-MDS. To determine the best strategy of geriatric assessment will allow in a second time to measure the impact of the use of this geriatric standardized evaluation by comparing patients'care and prognosis according to the use or not by the doctors of the new scores. Research outcomes are various medical, economic and ethic. Medical because decision-making will be improved with simplified geriatric assessment; economic because a better knowledge of geriatric assessment will improve treatment toxicity prevention and decrease treatment costs. Ethic will be associated with this project because a better knowledge of geriatric assessment tools to predict survival and tolerance treatment could improve the choice of best supportive care if prognosis markers are not favorable to active therapy. This project could induce important modification of practice in this area to an improved personalized treatment and simplification of geriatric assessment allowing a large diffusion in hospitals and clinics.
Hemospray™ is a new endoscopic hemostatic powder. Aims of this multicenter prospective study is to determine effectiveness of Hemospray™ on short and medium term in different clinical situations, predictive factors of rebleeding after Hemospray™ application, and feasibility of the application of hemostatic powder in routine clinical practice studying in a large sample of patients.
Is pneumococcal conjugate vaccine (which induces a T-dependent humoral response) more efficient than pneumococcal polysaccharide vaccine (which induces a T-independent humoral response) in RA patients treated with abatacept, biotherapy targeting T-cells? The investigator propose to conduct a prospective, multicenter (11 centers), randomized, open-label study. The patients are going to be randomized in 2 groups: patients of the first group will be vaccinated with the polysaccharide pneumococcal vaccine (Pneumo23®/Pneumovax®) whereas patients of the second group will be vaccinated with conjugate pneumococcal vaccine (Prevenar13®).
The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.