INTERVENTION/TREATMENT

Device:

• Open-loop condition
• Closed-loop condition

Summary

This clinical trial is a randomized trial including a 3-month single-arm part and a 6-month extension phase.

Following randomization between the 1st group and 2nd group, a 2-week baseline period in open-loop for 148 adults and 30 adolescents will be performed. Patients will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6.

INTERVENTION/TREATMENT

Device: Corvia Atrial Shunt System / IASD System II
Other: Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)

Summary

Following supine bicycle exercise hemodynamic assessment to verify eligibility, patients are sedated then randomized to the treatment or control group. Patients in both arms will undergo placement of femoral venous access sheath.

Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and Corvia Atrial Shunt implant procedure. Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.

INTERVENTION/TREATMENT

Device:

• Physica Kinematic Retaining Knee System
• Physica Cruciate Retaining Knee System
• Physica Posterior Stabilized Knee System
• Physica Cruciate Retaining Knee System with LMC Liner

Summary

The primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported outcome measures, and radiographic data for the commercially available Physica system. For ancillary arm, from baseline to 5-year follow-up.

INTERVENTION/TREATMENT

Drug: XON7

Summary

This is a two-stage trial consisting of a Part I, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), if any, and Recommended Part 2 Dose (RP2D) of XON7, followed by a Part II component to investigate anti-tumors efficacy in selected solid tumor types and to further evaluate safety and tolerability of XON7 at RP2D.

INTERVENTION/TREATMENT

Drug:

• PROTHERACYTES
• Standard Treatment for CHF post AMI

Summary

A multicentric controlled phase I / IIb study evaluating the safety and the efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process, and injected in patients with an acute myocardial infarction and a LVEF remaining below 50% versus standard of care.

INTERVENTION/TREATMENT

Biological: denovoSkin(TM)
Other: STSG

Summary

This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin.

INTERVENTION/TREATMENT

SENATOR software generated pharmacotherapy advice report.

Summary

Primary Objective: To quantify the benefits of the SENATOR decision support software on the reduction of ADR rates in older hospitalized patients.

There are two study phases:

• Phase I: Prospective multinational, multicentre observational study to estimate the baseline adjudicated medical and surgical ADR rates by clinical subspeciality in 6 international sites.
• Phase II: Prospective multinational, multicentre, block randomized, two parallel arm, open label, controlled trial, with blinded outcome ascertainment, of the efficacy of SENATOR software in reducing ADRs in older hospitalized subjects.

INTERVENTION/TREATMENT

Drug:

• R-CHOP
• R-CHOP / R-HAD
• Rituximab
• Lenalidomide

Summary

This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance improves progression free survival (PFS) compared to standard rituximab maintenance after induction treatment consisting of R-CHOP + R-HAD vs R-CHOP alone in older patients (≥ 60 year old) with mantle cell lymphoma.

The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28 alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab).

INTERVENTION/TREATMENT

Health check-ups, education and personalised support

Summary

Therapeutic Patient Education (TPE, Éducation Thérapeutique du Patient – ETP) programs conducted within the French Centres d'Examen de Santé (CES) are structured initiatives aimed at helping patients better understand and manage chronic diseases.
Delivered as part of preventive health services, these programs combine medical assessment, education, and personalized support to improve long-term outcomes and patient autonomy.
The initiative, initially led by CETAF (now integrated into the CPAM de la Loire), targets several major public health conditions, including type 2 diabetes, chronic obstructive pulmonary disease (COPD), asthma, and cardiovascular risk factors.