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Actively Recruiting

Researchers are evaluating the relationship between the Chelsea Critical Care Physical Assessment Tool (CPAx) score at ICU discharge and the distance walked during a 6-minute walk test (6MWT) performed three months later. This observational study focuses on patients who had prolonged mechanical ventilation and were treated in the ICU at CHI Elbeuf-Louviers-Val-de-Reuil. Eligible participants show signs of malnutrition, muscle weakness, or post-traumatic stress symptoms. The goal is to see if the CPAx score can predict long-term recovery and help guide rehabilitation after ICU care. Participants will have their respiratory function, cough ability, bed mobility, sitting, standing balance, transfers, stepping, and grip strength evaluated using the CPAx at ICU discharge. The study does not involve any interventions but collects data on these assessments, along with the 6MWT distance measured three months after discharge. The follow-up occurs during routine visits at the day hospital. No experimental treatments are administered. During the study, participants will be assessed using the CPAx at ICU discharge and then complete the 6MWT three months later to measure functional recovery. Researchers will collect clinical and demographic information, including muscle strength scores and psychological symptoms. The main outcome measure is how well the CPAx score predicts the 6MWT distance after three months. The study poses minimal risk and involves standard evaluations during normal follow-up visits.

Age: 18Years +All Genders
1 location
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Actively Recruiting

Researchers are evaluating immunotherapy treatments, such as anti-PD-1, PD-L1, or CTLA-4 inhibitors, in patients with various metastatic cancers that have shown response after 6 months of standard immunotherapy. This phase III randomized trial aims to compare the standard immunotherapy administration schedule with a reduced dose intensity schedule, given every three months, to see if the less frequent dosing can prevent disease progression just as effectively. The study is motivated by the need to find an optimal immunotherapy duration that balances treatment effectiveness, toxicity, patient quality of life, and cost. Participants will be randomized to continue either the standard immunotherapy schedule or switch to receiving the same immunotherapy drug every three months after an initial 6-month period of standard treatment. Treatment will continue until disease progression, unacceptable side effects, death, or a decision to stop treatment by the patient or investigator. This approach is based on evidence suggesting that immunotherapy drugs have long-lasting effects beyond their serum half-life and that less frequent dosing might maintain treatment effectiveness. Throughout the study, patients will undergo regular assessments including radiological imaging to determine disease response and progression, using RECIST or PERCIST criteria. The primary outcome measured is progression-free survival from randomization up to three years. Safety, toxicity, and patient quality of life will also be monitored. Participants must comply with scheduled visits and examinations, and the entire study duration includes treatment and follow-up periods to evaluate long-term outcomes.

Age: 18Years +All GendersPhase 3
40 locations
Saint Aubin Les Elbeuf Clinical Trials | DecenTrialz