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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Bronchiectasis is a chronic lung condition where parts of the bronchial tubes become permanently widened, leading to mucus buildup, infections, and ongoing inflammation. Managing this disease often includes respiratory physiotherapy to help clear mucus. However, accessing this therapy regularly can be difficult due to time, location, and availability of trained professionals. Researchers are evaluating the long-term use of the SIMEOX device, which uses brief air pressure pulses to help loosen and move mucus, combined with remote physiotherapy, to improve the quality of life and reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis. The study compares two groups: one using the SIMEOX device daily at home along with remote physiotherapy sessions, and a control group receiving enhanced standard care plus remote physiotherapy. The remote physiotherapy is delivered monthly for the first three months and then every three months afterward. The study lasts on average 24 months, allowing assessment of the device's effects over the mid and long term. Participants will be monitored through quality of life questionnaires and tracking of pulmonary exacerbations during the study. Evaluations include respiratory assessments and ensuring participants can use the device and follow procedures. The main outcomes measured are changes in respiratory quality of life after six months and the annual rate of lung exacerbations over the full study period. Safety and treatment adherence will also be continuously reviewed throughout participation.

Age: 18Years +All GendersPhase Not Applicable
57 locations
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Actively Recruiting

Researchers are evaluating the effectiveness of a low-protein diet (LPD) using specially developed low-protein foods (FLAVIS products) compared to a standard low-protein diet without these foods in patients with chronic kidney disease (CKD) stages 3A to 5 who are not on dialysis. The study follows recommendations from the KDOQI 2020 clinical practice guideline, which suggests restricting protein intake to reduce the risk of end-stage renal disease and improve quality of life. The FLAVIS products are designed to help patients achieve nutritional goals more easily while following a low-protein diet. Participants are divided into groups where one group receives FLAVIS products alongside their diet follow-up, while the other group follows the low-protein diet without these products. The study aims to monitor protein intake over a 12-month period to assess how effective the FLAVIS products are in facilitating adherence to the diet and meeting protein intake targets. During the study, participants will attend scheduled visits and complete diet records and self-administered questionnaires to track their adherence and nutritional status. Researchers will measure protein intake as the primary outcome after 12 months. Participants must be motivated to follow a low-protein diet and have good nutritional status at the start. Safety monitoring includes assessing any adverse effects and ensuring participants can provide blood samples and perform 24-hour urine collections as required.

Age: 18Years +All GendersPhase Not Applicable
21 locations
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Actively Recruiting

Colorectal cancer mainly affects elderly patients, with over half of new cases in France occurring in those aged 70 or older. Adjuvant chemotherapy has shown benefits in disease-free and overall survival after stage III colon cancer surgery, but its use in elderly patients remains limited. This phase III randomized study explores whether adjuvant chemotherapy improves disease-free survival in elderly patients and which chemotherapy regimen is most effective, addressing concerns about benefits for both unfit and fit elderly patients. Participants will be divided into two groups based on a multidisciplinary evaluation including a geriatrician. One group will receive fluoropyrimidine-based chemotherapy (LV5FU2 or capecitabine), and the other will receive oxaliplatin-based chemotherapy (FOLFOX4 or XELOX). Some patients may be assigned to observation only. Treatments will begin within 12 weeks after surgery. The study also evaluates specific biological markers common in elderly tumors, such as mismatch repair deficiency. During the study, participants will undergo assessments including geriatric questionnaires and medical monitoring. Researchers will track disease-free survival over three years following the last patient's enrollment. Safety and treatment effects will be monitored, with exclusion of patients expected to live less than four years or those unable to comply with follow-up. The study aims to better understand chemotherapy benefits in an elderly population after colon cancer surgery.

Age: 75Years +All GendersPhase 3
140 locations