Saugnac-et-cambran, France
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 HospitalTarbes
Recruiting
Effectiveness of the WHO ICOPE (Integrated Care for Older People) Program in Preventing Age-related Functional Decline (ICOPE Trial.Fr)
ICOPE Trail.Fr is a comparative, multicenter, randomized (1:1), two-arm parallel intervention trial, stratified by center and the number of impairments present at inclusion, open-label, controlled, comparing the effectiveness of the comprehensive ICOPE strategy in preventing functional decline in elderly individuals aged 70 and over living at home, versus the usual care provided by their primary care physician. Participants will be randomized either 1) into the Intervention group, where they will receive the comprehensive ICOPE intervention program, adapted and personalized to their areas of deficit, or 2) into the Control group, where they will be referred to their primary care physician to receive usual care tailored to their health status. Follow-up visits take place at the investigator's center at V2 (12 months), V3 (24 months), V4 (36 months), V5 (48 months), and V6 (60 months). Data related to functional scales are collected by the research nurse, who is blinded to the randomization results. Phone calls will be at 6 (A1), 18 (A2), 30 (A3), 42 (A4), and 54 (A5) months to collect relevant life events. The intervention duration is 36 months, followed by a 24-month extension phase during which all study participants will receive the comprehensive ICOPE intervention.
Phase
N/ASpan
368 weeksSponsor
University Hospital, ToulouseTarbes
Recruiting
Evaluation of the Vivo Isar Stent System in Routine Clinical Practice
Phase
N/ASpan
162 weeksSponsor
Translumina GmbHTarbes
Recruiting
Asciminib Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France
The ASSURE-3 study is a national, multicentric, non-interventional, prospective study in real-life conditions with primary data collection in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more Tyrosine Kinase Inhibitors (TKIs). It will be conducted in France with hematologists, onco-hematologists, physicians with documented involvement in managing Ph+ CML-CP patients in routine practice, practicing in public or private health care institutions. Each patient will be followed during 15 months at M0, M1 and then every 3 months (rhythm of visits according to the routine clinical care), or until premature discontinuation of asciminib treatment. Historical data will be abstracted retrospectively by the participating physicians from patient files, to collect information using an electronic case report form (eCRF). Primary data will be collected during inclusion and follow-up visits
Phase
N/ASpan
145 weeksSponsor
Novartis PharmaceuticalsTarbes
Recruiting
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
Phase
N/ASpan
162 weeksSponsor
Fresenius Kabi, FranceTarbes
Recruiting
Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU ('Autorisation Temporaire d'Utilisation') OR or Authorisation for Early Access (AAP). A Prospectvie Cohort.
Phase
N/ASpan
93 weeksSponsor
ANRS, Emerging Infectious DiseasesTarbes
Recruiting
Chemotherapy and Immunotherapy as Treatment for MSS Metastatic Colorectal Cancer With High Immune Infiltrate
Phase
2Span
182 weeksSponsor
Federation Francophone de Cancerologie DigestiveTarbes
Recruiting
Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers
Comparative interventional prospective phase 3, randomised, open-label, multicentric trial comparing the combination of radiotherapy and pembrolizumab alone or with chemotherapy to systemic treatment as first line treatment of patients with newly diagnosed head and neck squamous cell carcinoma with synchronous metastases.
Phase
3Span
409 weeksSponsor
UNICANCERTarbes
Recruiting
Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock
Sepsis is a common syndrome responsible for multiple organ failure. Septic shock, defined as sepsis with hyperlactatemia and cardiovascular failure requiring vasopressor infusion despite adequate fluid resuscitation has an extremely high mortality rate. Fever is a frequent disease process during sepsis. Fever increases oxygen consumption and can worsen imbalance between oxygen supply and oxygen requirements. Fever increases inflammation but reduces viral and bacterial growth. The beneficial effects of active fever control on inflammation have been mainly shown in a context of lung injury. Pneumonia represents the first cause of septic shock in developed countries. In a pilot study (SEPSISCOOL I), we showed that fever treatment using external cooling significantly increased the resolution of shock, improved organ functions and decreased d-14 mortality. Although reduced, hospital mortality was not significantly different. This study was underpowered to allow conclusion on mortality. A more pronounced beneficial effect was observed among the most severely ill patients with elevated serum lactate level. Fever treatment is commonly applied in septic patients but its impact on survival remains undetermined. The main objective of the study is to compare two strategies of fever management in febrile (body temperature > 38.3°C) septic shock patients requiring invasive mechanical ventilation and sedation. These patients will be randomly allocated in two arms: 1. Fever respect 2. Fever control by external cooling to obtain normothermia during 48 hours A covariate-adaptive randomization will be used to ensure the comparability of the two groups at each stage of the study. We will use an adaptive multistage population-enrichment design with a pre-specified subgroup of patients with ARDS identified at randomization. An independent Safety and Data Monitoring Committee will review data on serious adverse events. The decision of study stop for potential harmful effect of one strategy will be let at the entire responsibility of the committee. One interim analysis will be performed by independent observers after enrolment of half of the population. The assumption that fever treatment is more effective in patients with ARDS will be confirmed or not. According to pre-defined rules based on the conditional power calculated in the two subgroups, the trial will be stopped for futility, continued as planned or continued by enrolling only patients with ARDS.
Phase
N/ASpan
218 weeksSponsor
Centre Hospitalier Intercommunal CreteilTarbes
Recruiting
Covid-19 Pediatric Observatory
Phase
N/ASpan
221 weeksSponsor
Centre Hospitalier Intercommunal CreteilTarbes
Recruiting