Bihorel, France

SAPHIR : Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI or Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases

In a population of adult patients who are targeted to initiate adalimumab or previously treated with Humira® to get switched to a biosimilar (FK adalimumab) and followed up for a period of 12 months under routine medical practice conditions. - Primary objective: to define predictive factors for the persistence of treatment - Secondary objectives: - To assess the therapeutic benefit and the tolerability of the treatment - To describe the reasons for treatment discontinuations occurring during follow-up

Physiological Effects of HFNC During Exercise in Patients With Fibrosing Interstitial Lung Diseases

Comparison of the Cardiopulmonary and Gaz-exchange Response Between the Six-minute Stepper Test and the Incremental Cardiopulmonary Exercise Testing in Patients With Chronicle Obstructive Pulmonary Disease

Experimental design: This study is a pre-specified ancillary study to two other studies (with exactly the same design but a different population) aimed to assess the usability of the six-minute stepper test to prescribe endurance training in patients with mild to moderate (NCT02842463) and severe to very severe (NCT04004689) chronicle obstructive pulmonary disease respectively. Patients already participating in one of these studies will be approached and offered to participate in an additional testing session (on a different day) using exactly the same procedure but monitoring cardiopulmonary parameters and gaz exchanges using a face mask, a pneumotachograph and a gaz analyser (indirect calorimetry). Data from these additional two six-minute stepper tests will be compared with those obtained from the previously performed incremental cardiopulmonary exercise testing. According to the American Thoracic Society and American College of Chest Physicians statement on cardiopulmonary exercise testing, maximality will be considered if either one or more of the following criteria occured: 1. The patient achieves predicted peak oxygen uptake and/or a plateau is observed. 2. Predicted maximal heart rate is achieved (>90%) 3. There is evidence of ventilatory limitation (breathing reserve <11liters or < 15%) 4. Respiratory exchange ratio > 1.15 5. Patient exhaustion/Borg Scale rating of 9-10 on a 0-to-10 scale. Phase II oxygen consumption kinetics will be modelized by averaging the breath by breath measurement over consecutive periods of 5s for using the following monoexponential equation : VO2 (τ) = VO2rest + VO2ss - VO2rest))*(1-e-t/τ). with " VO2rest " representing the baseline level of VO2 at rest, " VO2ss " representing the steady state of VO2 during exertion and τ (time constant) representing the time course of the monoexponential VO2 curve. The amplitude of the VO2 (VO2span) corresponds to the difference between VO2ss and VO2rest. A curve by curve analysis will be performed across participants and parameters (time constant, span and steady state oxygen consumption) will be compared according to the stage of severity.

6-minute Stepper Test and Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronicle Obstructive Pulmonary Disease

Experimental design: The validation of the six-minute stepper test to prescribe endurance training in severe to very severe chronicle obstructive pulmonary disease involves two steps : 1. Patients with severe to very severe chronicle obstructive pulmonary disease who performed an incremental cardiopulmonary exercise testing and are referred to pulmonary rehabilitation will be approached to participate in the study. Eligible patients who agree to participate in the study and sign informed consent will perform two six-minute stepper test. Their performance and heart rate (first and last 3minutes) will be compared with those obtained at the first ventilatory threshold from the previously performed incremental cardiopulmonary exercise testing (usually used for the prescription of endurance training in pulmonary rehabilitation) using multiple regression in order to derive a predictive equation. 2. The validity of this predictive equation will be assessed in an independent cross-validation group issued from a completed multicenter observational study (NCT03244137). This cross-validation group will be formed with those patients of this cohort who performed both the incremental cardiopulmonary exercise testing (and had a determined first ventilatory threshold) and the six-minute stepper test. The heart rate prescription for endurance training from the direct measurement of the the first ventilatory threshold will be compared to the heart rate derived from the 6minute-stepper test using the predictive equation determined in step 1. Data will be compared using the mean absolute difference between both prescriptions and a Bland-Altman analysis.

Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer

The purpose of the study is to optimize survival by an adapted metabolic imaging therapy in patients with advances non-small cell lung cancer. The primary objective of the study is to evaluate the role of SUV and metabolic volume measured by FDG PETScan in the early prediction of treatment response. 80 patients will be included in 2 years. They will be follow up for one year for monitoring the progression free survival.

Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients

Optimizing the management of type 2 diabetes (T2D) will remain a major public health concern for decades to come. T2DM has already affected 4% of the French population and generates each year over 12 billion euros of expenditure. By combining therapies, oral and/or injectable (insulin or analogues of GLP-1), the current management of T2DM provides two thirds of patients with a satisfactory metabolic control (HbA1c < 7%) and reduced incidence of cardiovascular complications. Its effect on mortality, however, remains more limited, presumably because of the persistence of other cardiovascular risk factors. A recent study has confirmed that French patients with T2DM present an overall mortality risk significantly higher than the general population. In France, this group registered a mortality of 32 deaths per 1000 persons. Bariatric surgery is now a recognized method for the treatment of severe obesity. It allows for the permanent loss of at least 50% of initial excess weight. In obese patients, this surgery is also associated with a significant reduction in cardiovascular risk factors and particularly T2D. A recent meta-analysis of retrospective studies available suggests that surgery results in remission of T2DM in over 75% of cases. The only prospective randomized study showed that gastric restriction by placing a gastric band, provides better glycemic control than just medical treatment in obese patients with recently discovered T2DM. The gastric by-pass (GBP) which also includes an intestinal by-pass, seems to have an even higher metabolic efficiency than gastric bypass alone. In patients with T2DM, the GBP restores postprandial insulin secretion independently of weight loss. Despite the significant morbidity of the intervention, long-term results seem broadly supportive of the GBP. In a large case-control study, GBP was associated with a decrease of 90% of deaths related to diabetes. In a controlled study conducted in surgical candidates obese diabetics, the GBP decreased the overall world mortality by 75% after 6 years. Despite these very encouraging data, the GBP is now proposed to only a small proportion (< 1%) of patients likely to benefit from the procedure.

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders

Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.