San Mate, California
Integrated Management of Chronic Respiratory Diseases
Chronic respiratory diseases such as obstructive sleep apnea syndrome (OSA) and chronic obstructive pulmonary disease (COPD) constitute a major public health problem, due to their high prevalence, but especially because of their cardiovascular and metabolic morbidity and mortality and the associated costs for the health system. There is also an inequality of access to referral care linked to demographics and territorial organization. We are currently at a turning point in the understanding of these pathologies and their coordinated management by combining therapeutic modalities. The organization of long-term management of these diseases is now part of the e-health process, digital health with the use of massive "big data" generated by care and follow-up. Therapeutic patient education and the integration of connected objects measuring weight, oxygen saturation rate, heart rate, respiratory rate, skin temperature blood pressure or physical activity will allow personalized therapeutic education support with interventions by local medical staff adapted to the needs of the patients. This will also allow to objectify the effect of treatments such as continuous positive airway pressure (CPAP) for OSA or non-invasive ventilation (NIV) and/or oxygen therapy for COPD, not only on the prevention of respiratory decompensation but also on cardiovascular and metabolic risk factors which are major elements of the prognosis. This project will therefore make it possible to demonstrate the feasibility and to deploy a multi-actor care pathway in the territory. The investigators propose a prospective clinical study, conducted at the Verdun Hospital, with the main objective of studying the evolution of the quality of life of patients with a chronic respiratory pathology, during an integrated management at home for 6 months. The secondary objectives: - To study the evolution of the following parameters, before treatment (at inclusion) and after 6 months of integrated management: 1. Treatment compliance (CPAP or NIV/oxygen therapy) 2. Physical activity, measured by an actimeter for OSAS patients or by the BORA Band device for COPD patients, for one week and IPAQ 3. Weight, measured by a connected scale 4. Average blood pressure, measured by a connected blood pressure monitor 5. Oxygen saturation, heart rate and respiratory rate measured by the BORA Band for COPD patients 6. The severity of COPD by the EXASCORE questionnaire for the patients concerned 7. Daytime sleepiness by the Epworth questionnaire 8. Fatigue by the Pichot scale 9. Patients' acceptability of the use of the connected objects by questionnaires of satisfaction of use at 6 months. - To analyze the trajectories of the measures collected throughout the integrated management to identify specific profiles. - To analyze the daily data of the different connected objects and treatments with regard to the patients' profiles (according to age, gender, comorbidities, OSA or COPD group).
Phase
N/ASpan
181 weeksSponsor
University Hospital, GrenobleVerdun
Recruiting
Extern Validation of a Predictive Score of Brain Death in Severe Stroke (DIAPASON1)
Main objective : External validation of a brain death evolution predictive score GRAHAL65 (initial Glasgow score ≤6, systolic blood pressure >150 mmHg, past history of alcohol abuse, herniation, hydrocephalus, and stroke volume>65 ml) for patients with severe stroke and withhold therapy built. Secondary objectives : Identification of other clinical and paraclinical predictive factors of brain death evolution: - Age,sex, - Temperature and glycemia - Rostro-caudal abolition of brainstem reflexes - Other cardiovascular risk factors (hypertension, diabetes, atrial fibrillation, dyslipidemia,) - Antiplatelet therapy, anticoagulant treatment, - Intravenous thrombolytic therapy or thrombectomy - Type of stroke - Infarct location - Type of brain herniation
Phase
N/ASpan
143 weeksSponsor
Central Hospital, Nancy, FranceVerdun
Recruiting
Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis.
Immunosuppressive therapy of granulomatosis with polyangiitis (GPA, Wegener's) and microscopic polyangiitis (MPA) has transformed the outcome from death to a strong likelihood of disease control and temporary remission. However, most patients have recurrent relapses that lead to damage and require repeated treatment associated with long-term morbidity and death. Rituximab has been shown to be as effective as cyclophosphamide to induce remission and maintenance of remission in severe GPA and MPA patients, with an acceptable safety profile. Although rituximab is becoming the standard of care for maintenance therapy in these patients, relapse still occurs and the optimal duration of prednisone therapy remains debated. On the one hand, most US studies use early withdrawal (6-12 months) because of feared side effects. On the other hand, most European trials propose late withdrawal (>18 months) given a lower observed relapse rate on long-term low dose glucocorticoids treatment. In a systematic review and meta-analysis, glucocorticoids regimen was the most significant variable explaining the variability between the proportions of ANCA-associated vasculitis patients with relapses. Nevertheless, it was an indirect estimation of treatment effect because of the absence of dedicated randomized trial. This meta-analysis concluded that combined longer-term (i.e. >12 months) use of low dose prednisone or nonzero glucocorticoids target is associated with a 20% reduction of relapse compared to early withdrawal (i.e. ≤12 months). The relapse rate in patients with early glucocorticoids (10-12 months) withdrawal was provided in two studies and was of 37 and 34%, respectively. By contrast, the relapse rate in patients with late prednisone withdrawal (18-24 months) and receiving rituximab as maintenance treatment was 14% at 24 months in the MAINRITSAN trial. Of note, the decision to withdraw glucocorticoids after 18 months was left to physician's discretion in this study and two thirds of the nonsevere relapses occurred when patients were off prednisone. The trial detailed here is the first prospective trial evaluating the length of glucocorticoid administration as remission adjunctive treatment for patients with GPA or MPA.
Phase
N/ASpan
250 weeksSponsor
Hospices Civils de LyonVerdun
Recruiting
Biological Dating of Cerebral Ischemia With GST-π/PRDX1 to Detect Patients With Stroke of Unknown Onset Within the Therapeutic Window of Thrombolysis
Phase
N/ASpan
333 weeksSponsor
Central Hospital, Nancy, FranceVerdun
Recruiting
Impact of an Early and Extended Rehabilitation Program Combining Individually Tailored Nutrition and Physical Activities on Patient Outcomes After Invasive Mechanical Ventilation and Vasopressor Therapy in the ICU
Phase
N/ASpan
157 weeksSponsor
Nantes University HospitalVerdun
Recruiting
Study of the Value of Maternal-fetal Transfers and Their Complexity of Their Implementation
Over the past year, an audit carried out on the Mercy maternity unit, covering 130 transfers to the Nancy regional maternity hospital, showed that patients transferred for threat of premature delivery (MAP) with a cervix > 15 mm do not give birth at the receiving maternity unit, but return home after 48 hours' hospitalization. When maternal-fetal transfer (MFT) is requested, numerous calls are made to private ambulance services, and in the end, many emergency rapid response units (SMUR) are called out, requiring a major human, logistical and time investment for a questionable benefit to the patient. Tensions in terms of logistics (lack of ambulance, SMUR) and human resources (lack of personnel) can, conversely, compromise good care of the parturient.
Phase
N/ASpan
53 weeksSponsor
Centre Hospitalier Régional Metz-ThionvilleVerdun
Recruiting