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NCT ID: NCT06068595 Not yet recruiting - Clinical trials for Musculoskeletal; Anomaly

Evaluation of the Contribution of Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy

ECHOSTEOM
Start date: April 2024
Phase: N/A
Study type: Interventional

The hypothesis of this study is that musculoskeletal point of care ultrasonography would support the GP's decision and ultimately improve patient management. The aim of this study is to evaluate, in the context of suspected musculoskeletal abnormality, the contribution of musculoskeletal point of care ultrasonography to the general practitioner's overall decision-making strategy, defined according to the following 5 axes: diagnosis (I), therapy (II), patient orientation (III), prescription of complementary examinations (IV) and follow-up (V).

NCT ID: NCT06068361 Not yet recruiting - Alzheimer Disease Clinical Trials

Diagnostic Evaluation of Dementia With Lewy Bodies Using a Multimodal Approach

EEG-EDELY
Start date: July 2024
Phase:
Study type: Observational

Dementia with Lewy body disease (DLB) is the second leading cause of degenerative cognitive disorder after Alzheimer's disease (AD). Its variable clinical expression makes diagnosis difficult. To date, there is no validated DLB diagnostic biomarker, despite several biomarkers in development (EEG, MRI, biology). Studies have shown that an improvement in diagnostic performance could be obtained by combining different modalities biomarkers using machine learning. The aim of this research is to identify the best combination of multimodal biomarkers for the diagnosis of DLB (EEG, MRI, biology, cognitive scores), using a machine learning approach applied to a clinical cohort.

NCT ID: NCT06066762 Not yet recruiting - Clinical trials for Heparin-induced Thrombocytopenia

Argatroban Monitoring in Acute Suspected Heparin-induced Thrombocytopenia.

TIH-FM
Start date: November 1, 2023
Phase:
Study type: Observational

Heparin-induced thrombocytopenia (HIT) is a rare but potentially serious complication of heparin therapy. , argatroban is the alternative anticoagulant of choice in patients with suspected HIT and renal impairment, high bleeding risk or risk of invasive surgery/gesture. Despite its increasing use in these fragile patients, methods for biological monitoring of argatroban's anticoagulant activity are heterogeneous, and neither the therapeutic zone nor the modalities for argatroban dosage adjustment are clearly defined, particularly in patients in the acute phase of thrombosis. Soluble fibrin monomers (FM) indirectly reflect thrombin generation in vivo. This marker could thus represent a new strategy for monitoring the anticoagulant activity of argatroban. However, the effect of argatroban anticoagulation on FM levels remains unknown. In a preliminary retrospective study carried out at Bichat hospital, we showed that FM levels could therefore be an early marker of the efficacy of argatroban treatment in patients with suspected HIT.In order to confirm these results, we will include patients with clinico-biological suspicion of HIT and receiving argatroban treatment. Ten French laboratories will participate in this study. All plasmas collected will be from samples taken only in the context of care. This prospective study will determine whether the daily monitoring of FM is beneficial for the management of patients treated with argatroban.

NCT ID: NCT06066736 Not yet recruiting - Clinical trials for Ventilator-associated Pneumonia

Risks Factors and Outcome of Recurrences in Patients With Ventilator-Associated Pneumonias (REVAP)

REVAP
Start date: December 1, 2023
Phase:
Study type: Observational

Ventilator-associated pneumonia (VAP) is a frequent and serious complication in the ICU, defined by the development of a lung infection in patients ventilated for more than 48 hours. The incidence rate of this condition exceeds 18 episodes per 1000 days of mechanical ventilation in Europe. This nosocomial infection is associated with the highest mortality, ranging from 24% to 76% depending on the series. Reducing the incidence of VAP remains a challenge for clinicians, as evidenced by the many recent recommendations that have led to "bundles" to prevent the onset of this complication. Despite this, these recommendations do not propose a strategy to prevent the recurrence of PAVM, a frequent entity with a reported incidence of 25-35% and a non-consensual definition that increases antibiotic consumption, duration of mechanical ventilation and length of stay in the ICU . In fact, these recurrences can be linked to: - Intrinsic patient risk factors (immunosuppression, severity of disease, major inflammatory response, reason for initial admission), - Inappropriate initial antibiotic therapy (type, duration and dose administered), - Characteristics specific to the pathogens encountered (virulence factors or resistance), - Intercurrent complications during management of the initial pneumonia (ARDS, abscess, pleural empyema). Given the frequency of these recurrences, and the persistent doubts about the role of terrain and pathogen characteristics in their genesis, it seems appropriate to look at risk factors that could help anticipate these events. The aim of our study will be to identify the risk factors and mortality associated with the occurrence of a recurrence of VAP in patients hospitalized in the intensive care unit. An essential first step in this work will be to identify and then use the most consensual definition of recurrence of VAP, encompassing recurrence, persistence and superinfection. We will use the definitions in the protocol for the ASPIC trial, which is currently undergoing enrolment. The second step is to identify risk factors for recurrence. By identifying these factors, it could be possible to propose a prognostic score that would enable careful monitoring (or modification of antibiotic therapy) of patients most at risk of recurrence. Such a score could then be evaluated in a prospective study.

NCT ID: NCT06061705 Not yet recruiting - Clinical trials for Squamous Cell Carcinoma of the Oropharynx

Identification of Individual Histological and Blood Markers in Patients With Recurrent or Metastatic Upper Aerodigestive Tract Squamous Cell Carcinoma in Response to Immunotherapies

iMonitORL
Start date: December 30, 2023
Phase: N/A
Study type: Interventional

Epidermoid Carcinoma of the Upper Aerodigestive Tract (CEVADS) is the 6th most common cancer worldwide. Despite current therapies (radiotherapy, surgery and chemotherapy), cancers of the Upper Aerodigestive Tract (UAT) have a poor prognosis, with a 10-year survival rate of no more than 20%. For recurrent or metastatic CEVADS, the therapeutic arsenal, based for many years on chemotherapy and anti-EGFR (Epidermal Growth Factor Receptor) agents, has been enriched by a new therapeutic class: PD-1 inhibitors. For CEVADS, PD-1 inhibitors have been approved for second-line treatment of nivolumab for over a year, and are now used in first-line treatment of pembrolizumab. The results of this therapeutic class in CEVADS are not as spectacular as for melanoma or bronchial cancer. Indeed, only 20% of patients have a favorable response, compared with half who experience disease progression. This low proportion of responders can be explained by tumor heterogeneity within CEVADS and poor patient selection. The only marker used to select patients is PD-L1 expression detected by ImmunoHistochemistry (IHC). However, it seems that this marker, described as imperfect, is still little explored in ENT. It needs to be compared with the expression of other cell lines in the tumor microenvironment, which could play an important role in resistance to PD-1 inhibitors. IHC identifies all macrophages using the CD68 marker, while the CD163 marker is specific to M2 macrophages. Other targets in the microenvironment are also being investigated, with the discovery of a Tertiary Lymphocyte Structure (TLS) in melanoma treated with immunotherapy. It therefore seems necessary to gain a better understanding of the mechanisms of tumor progression under immunotherapy in order to develop strategies to optimize response to treatment. This would enable better selection of patients likely to benefit from immunotherapy, and open up prospects for therapeutic combinations. The hypothesis is that macrophages, but also other cells and factors in the CEVADS microenvironment, play a decisive role in resistance to PD-1 inhibitors. The aim is therefore to continue these macrophage analyses, extend them to other cells in the microenvironment and link them to other prognostic factors under investigation. A prospective study will analyze tumor tissue during treatment with PD-1 inhibitors, in order to correlate all the factors studied with response or resistance to immunotherapies. In addition, the oral microbiota, in the lineage of the intestinal microbiota, has been shown to be highly stable over time and to play a role in the oncogenesis of certain cancers, notably CEVADS. Like the intestinal microbiota, it could also represent a prognostic factor in the response to immunotherapies. Of all the bacteria in this oral microbiota, one has been shown to play a major role: Fusobacterium nucleatum (F. nucleatum). However, little is known about the mechanism of action of intratumoral F. nucleatum on the development of CEVADS. In particular, it is thought to play a role in local cancer immunity, via macrophages, regulatory T cells (Tregs) and TLRs. Finally, it appears that specific antimicrobial T-cell responses may cross-react with tumor antigens, hence the importance of also analyzing the metabolome of commensal bacteria.The aim of this study was to evaluate the evolution of the presence of this bacterium in saliva, as well as the specific immune response to F. nucleatum in patients with CEVADS during immunotherapy treatment.

NCT ID: NCT06059937 Not yet recruiting - Clinical trials for Patients Hospitalized for Pre-eclampsia

Evaluation of Cardiovascular Risk After Preeclampsia in General Practitioners and Patients

PreCarVasc
Start date: October 2023
Phase:
Study type: Observational

Pre-eclampsia is a disease characterized by placental damage leading to a cascade of complications during pregnancy. It is initially manifested by high blood pressure and the presence of albumin in the urine. It can lead to emergency hospitalization in severe cases and cause major complications or even death in the mother and the fetus. Several studies observing the outcome of patients with pre-eclampsia have shown an increased long-term cardiovascular risk in these patients, justifying regular medical follow-up with the treating physician and specialists, mainly cardiologists. The main objective of this research is to describe the cardiovascular risk assessment actions implemented by the treating general practitioner in the year following pre-eclampsia (blood pressure measurement in the office, self-measurement of blood pressure, ABPM, cardiological consultation, biological monitoring of blood (creatininemia, LDL, fasting glycemia) or urine (albuminurie/creatininurie ratio), and screening and management of possible smoking).

NCT ID: NCT06059430 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Cohort Project of Patients With Inflammatory Rheumatism

SMAP
Start date: September 20, 2023
Phase:
Study type: Observational

Chronic inflammatory rheumatism (CIR) is a group of inflammatory diseases that affect the joints and spine and are related to an abnormal immune response. CIR includes many different forms of arthritis that manifest as painful and swollen joints, stiffness, especially in the morning and persisting even after exercise, and limited joint mobility. CIR can also affect bones, cartilage, ligaments, tendons and muscles. Some may affect other organs. These symptoms can lead to a reduced quality of life, limited physical activity and progressive structural and functional deterioration of the joints. Current treatment for CIR is aimed at reducing inflammation and relieving pain. Anti-inflammatory medications such as corticosteroids and non-steroidal anti-inflammatory drugs can be used to relieve pain and inflammation. Biotherapies can also be used to modify the progression of the disease. On the other hand, regular exercise can help strengthen the muscles that support the affected joints and improve mobility. Physical therapies, such as physical and occupational therapy, can also help improve mobility and relieve pain. Although there is no definitive cure for CIR early and appropriate treatment can help reduce symptoms and improve quality of life, as well as avoid the risk of developing complications such as lung, cardiovascular, kidney, ophthalmic, liver and other diseases. It is in this context, in order to better understand CIR to improve the global management of patients, and to analyze the evolution of CIR over time in relation to the different treatments proposed, that the interest in creating a database of patients with CIR arises.

NCT ID: NCT06059092 Not yet recruiting - Emotional Distress Clinical Trials

Evaluation of Three School-based Mental Health Preventive Interventions in France

Start date: November 6, 2023
Phase: N/A
Study type: Interventional

To meet adolescents' needs regarding mental health vulnerability, this study aims to propose and evaluate three original school-based preventive interventions delivered to French 13y-adolescents, with respect to their effects on mental health outcomes, as well as users' experiences of intervention, evaluated through questionnaires. Based on cognitive-behavioral therapies (CBT) techniques, these interventions target three strategic process areas: reactive adaptation, proactive adaptation, and interpersonal adaptation. Their effectiveness will be evaluated through a four-arm randomized controlled trial, conducted in an ecological context. Intra-group and inter-group comparisons will be carried out for our different variables of interest, namely targeted psychological processes, levels of distress, functional impairment, and well-being, and user experience indicators of acceptability, utility, and usability.

NCT ID: NCT06056414 Not yet recruiting - Breast Neoplasm Clinical Trials

Study of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation

MBRESC
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

Performing a breast macrobiopsy can be extremely delicate and anxiety-provoking. It can have an impact on the course of future examinations. Patients' emotional feelings also have a definite impact on the nursing staff. The purpose of the MBRESC study is to evaluate Energy Resonance by Cutaneous Stimulation , a manual acupressure technique, in the management of anxiety prior to breast macrobiopsy.

NCT ID: NCT06054854 Not yet recruiting - Lung Cancer Clinical Trials

Biobank for the Identification of Biomarkers in Lung Cancer (BIRD, Biomarkers in Respiratory Disease)

BIRD-NK
Start date: June 1, 2024
Phase:
Study type: Observational

The BIRD biobank aims at collecting clinical and biological data from patients suffering from a chronic respiratory disease. The lung cancer subpopulation will be divided into two cohorts to identify biomarkers of cancer. One cohort will include patients with supra-centimetric lung nodule(s) whether surveillance, bronchoscopic or radio-guided biopsy or surgery is indicated, patients suspected of lung cancers requiring diagnostic and/or therapeutic bronchial endoscopy and patients with a known early stage lung cancer (early-stage cohort). The second cohort will include known advanced stage lung cancers (III-IV).