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.
This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.
Determination of the hemodialysis ultrafiltration volume is guided by the clinician's estimate of dry weight. A poor estimate of this dry weight may result in insufficient fluid depletion causing a state of volume overload, which may be associated with long-term left ventricular failure, high blood pressure and excess of mortality. The diagnosis of fluid overload in haemodialysis patient is routinely based on clinical examination which consists of cardiopulmonary auscultation and edema palpation of limb member. Clinical examination can be completed by paraclinical examinations, and bioimpedance is an objective tool that assess fluid overload state. This test provides an individualized hydration status and fluid overload based on normal extracellular volume considering body composition. Echocardiography allows an accurate assessment of blood volume status by simultaneous studying left ventricular filling pressures, systolic pulmonary artery pressure and the diameter of the inferior vena cava. Lung ultrasound analyses the B-lines defined as artefactual images resulting from contact between air in "alveoli" and water in "septa". It can estimate pulmonary congestion. The aim of the study is to evaluate the lung ultrasound using "8 sites" score accuracy for estimating fluid overload of patients before hemodialysis session.
"Nasal polyposis is a chronic inflammation of the sinonasal mucosa which is characterized by the development of polyps in the sinonasal cavities. In the general population, its prevalence is 4% with a clear increase from the age of 50 years. When drug treatment is not effective, and the patient's quality of life is impaired, surgery is proposed. It allows to widen the nasal cavities with aerodynamic and acoustics effects on speech. There are few studies, that have focused on the impact of NP and its treatment on speech. Yet there is a real demand from patients to obtain answers related to the impact of this surgery on their voice. Preoperatively and postoperatively, the resonance will be disturbed: polyps will impacted the quality of the nasal sounds. And after surgery, the new anatomical shape can create an excessive resonance in the nasal cavities. Indeed, there is a diversity of acoustic effects that differ according to the sinuses involved, the nature and type of surgery and the anatomical and physiological specificities of the patient. The impairment of acoustic properties after surgery is diverse and little known. The surgery improves the communication between sinuses and nasal cavities but the real impact on nasal resonance still unknown. The particularity of this pathology stands in the obstruction of the sinonasal cavity by polyps. On this study, it represents a model of nasality disturbance/impairment ? Indeed, all aspects of nasality will be altered : the articulation by the obstruction of the sino-nasal cavities, the aerodynamic by a disturbance of the circulation of the airflow within the nasal cavity, acoustics by an alteration of the resonance of this flow, and finally the perception of speech by others where the comprehension of speech is difficult. Thus, the investigators wish to observe this dysfunction in a multipara metric way in order to have an accurate approach. This population is therefore ideal. In preoperative, it will allow to measure by aerodynamic, articulatory, acoustic, and perceptive data taking this dysfunction, to give precise answers. Then, postoperatively, these measurements will be repeated to observe a return to the expected functioning of the nasal cavity. Indeed, the cavities being no longer congested, a greater flow of nasal air would be expected, which would have acoustic consequences on the resonance of nasal sounds. This could be accentuated because of the new anatomical configuration due to the surgery. Perceptually, the voice after surgery should no longer be considered as pathological. In addition to the linguistics aspect, this population has the particularity of having a strongly impacted quality of life. The investigators would therefore like to measure this impact on quality of life before and after surgery. For this study, the main objective is to measure the articulatory, aerodynamics, acoustics and perceptive impact of the nasal polyposis on speech before and after surgery. the secondaries objectives are to: - Compare the differences in aerodynamic, acoustic, articulatory and perceptual changes between the ""presence of polyps in the nasal and sinus cavities"" group and the ""presence of polyps in the sinus cavities"" group - Compare the modifications on the speech of the pathology before and after surgical treatment - Identify the elements related to the quality of life impacted by this pathology. - Identify the glottic compensation strategies induced by the pathology - Compare preoperative and postoperative nasal resonance and the relationship between nasal and sinus cavities using 3D models - Validate the adequacy of the nasality-speech questionnaire for patients with sinonasal polyposis"
Pain is a major problem in Intensive Care Unit (ICU). Adequate pain management not only means decreasing the pain intensity, but also improving the functionality and allowing the early mobilization that is a prerequisite for improving recovery and decreasing the risk of complications in ICU. The complex problems involved in pain, analgesic interventions, and outcome have been emphasized in several surveys over the past decades, but apparently with only small improvements, despite the existence of several guidelines for perioperative pain management. Regional analgesia techniques (peripheral and neuraxial nerve blocks) have the potential to decrease the physiological stress response to trauma or surgery, reducing the possibility of surgical complications and improving the outcomes. Recent studies suggested that surgical and trauma ICU patients receive opioid-hypnotics continuous infusions to prevent pain and agitation that could increase the risk of posttraumatic stress disorder and chronic neuropathic pain symptoms, and chronic opioid use. Also they may reduce the total amount of opioid analgesics necessary to achieve adequate pain control and the development of potentially dangerous side effects. The use of the regional anesthesia technique in the ICU, however, can, in part, be limited by the presence of hemodynamic instability, bleeding diathesis, and by the fear of the performing procedures potentially associated with significant side effects in heavily sedated patients. Although regional anesthesia emerges as a new and very interesting player for pain management in ICU, today very few data exists about the use of RA (including PNB and neuraxial nerves blocks) by the practicians in ICU/stepdown units. The main objective of this study is to assess the use of RA for pain management both initiates in the operative room for surgical patients then transferred in ICU/stepdown units and performs directly by the practicians in ICU/stepdown units, in several french units.
The decision to give fluids or not should not be taken lightly. Indeed, excessive or insufficient fluid administration is associated with increased morbidity and mortality. Prediction of fluid responsiveness relies on the use of a hemodynamic variable to determine how likely a patient is going to respond to a fluid bolus with a significant increase in their cardiac output or stroke volume. Depending on the response to fluids, patients are either responders or non-responders. Today, we have many techniques to predict fluid responsiveness. However, almost all require the use of an advanced hemodynamic monitoring device.
The objective of this study is to assess the superiority in achieving personal goals (set by the patient and the medical team) according to the GAS scale (Goal Attainment Scaling) while wearing the carbon medical device Ankle Foot Orthosis (AFO) compared to a standard plastic ankle foot orthosis.
Obesity is a major public health problem and Binge eating disorder (BED) is very frequently observed in patients considered for weight loss surgery and seems to influence their outcome critically. Literature highlights a global emotional overload in individuals with BED, but few are known on the mechanisms involved. The purpose of this study is to fill this gap by comparing the neurofunctional profiles of emotion regulation between patients suffering from obesity, with or without BED and healthy participants during the performance of emotion regulation tasks. Results may help to understand the neural bases of the impairments observed in patients with obesity, with or without BED, which may in turn help to propose, in the long term, potential new therapeutic approaches.
The aim of this study is to assess the influence of anterior abutment surgery using the Latarjet method on the kinematics of the scapula. The sub-objectives will be to show that Latarjet-type surgery does not lead to scapular dyskinesia and modification of muscle activity compared to a control group that has not undergone an operation.
Post-Market Clinical Follow-Up to evaluate the safety and performance of IDI dental implant systems : confirmation of osseointegration of the different implants at the loading visit (between 2 and 6 months after surgery).
The purpose of this study is to evaluate the effect of olezarsen (formerly known as AKCEA-APOCIII-LRx) on the percent change in fasting triglycerides (TG) from baseline.