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Found 6 Actively Recruiting clinical trials
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Swallowing disorders are common in patients who have difficulty being weaned from mechanical ventilation in intensive care units, especially those with tracheostomies. These disorders can lead to serious complications such as respiratory problems, nutritional issues, and even death. Current clinical examinations for swallowing disorders lack precision, and complementary tests like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES) are invasive, resource-intensive, and not easily accessible. Ultrasound imaging offers a promising, non-invasive alternative that can provide both qualitative and quantitative assessments of swallowing-related structures to improve diagnosis and rehabilitation targeting. This research aims to develop and evaluate a new ultrasound-based diagnostic model for detecting swallowing disorders in difficult-to-wean tracheostomised patients. Over a nineteen-month period, 119 eligible patients will be enrolled from multiple hospitals. Each participant will undergo a FEES evaluation and an ultrasound exam focusing on tongue movement, laryngeal motion, and suprahyoid muscles. Ultrasound assessments will be conducted with the operator blinded to other clinical data. The study will develop a predictive model using logistic regression and transform it into a practical scoring system to aid diagnosis. Participants will be assessed within a two-hour timeframe using FEES and ultrasound. Data collection includes demographic, medical history, and ultrasound measurements such as muscle thickness, movement, and echointensity. Reliability will be tested with repeated exams by different operators. The primary outcome is developing a swallowing disorder prediction model. Researchers will analyze the model’s sensitivity, specificity, and predictive value. Safety and validity will be closely monitored, and the study will provide a non-invasive tool to enhance early detection and personalized management of swallowing disorders in this patient population.
Actively Recruiting
Researchers are investigating how remote cooking workshops can help adults living with obesity improve their dietary habits. This study aims to compare two types of therapeutic cooking workshops—classic workshops with recipes provided by a dietician and creative culinary challenge workshops without set recipes—to see which better supports healthier eating. The goal is to assess improvements in diet quality based on national health nutrition guidelines, including increased fruit and vegetable intake, cooking frequency, and reduced consumption of pre-prepared ultra-processed foods. The study involves multiple hospitals in France and uses a stepped wedge cluster randomized design. Participants will join either classic or culinary challenge remote cooking workshops delivered via video conference, allowing them to cook from their own kitchens. The workshops encourage practical skills and creativity in meal preparation while being accessible remotely. The study compares the impact of these two approaches on participants' dietary balance over time. Participants will be adults with obesity who can cook at home and have access to video conferencing tools. They will complete various questionnaires throughout the study to track changes in their diet. Researchers will monitor adherence, dietary habits, and nutritional outcomes over a three-month period. Safety and eligibility will be carefully assessed, and the study seeks to provide clear evidence on the effectiveness of therapeutic cooking workshops in obesity management.
Actively Recruiting
Researchers are evaluating the effectiveness of auriculotherapy in treating xerostomia, a condition characterized by dry mouth, particularly in patients who have experienced cervical irradiation due to ENT cancer. The study aims to compare specific auriculotherapy following the "protocol of Alimi" with a non-specific sham auriculotherapy to see which approach better improves salivation after three months of treatment. Participants receive either three sessions of auriculotherapy with semi-permanent needles applied to six specific points at monthly intervals or three sessions on non-specific points as a comparison. The study is designed to assess the real auriculotherapy effects against the sham version over a three-month treatment period. During the study, participants will be monitored for improvements in saliva production. Researchers will measure the number of patients who experience improved salivation after three months of treatment. Participants must comply with treatment sessions and complete questionnaires as part of the study protocol, with safety and adherence closely observed throughout the process.
Actively Recruiting
Tapia syndrome is a rare condition caused by damage to the recurrent and hypoglossal nerves, leading to paralysis of one vocal cord and half of the tongue on the same side. This condition often causes difficulties with speaking and swallowing. Few cases have been reported in medical literature, and there is limited understanding of its prevalence and symptoms, especially regarding involvement of the soft palate. This study aims to determine how common Tapia syndrome is in patients admitted to a weaning unit after being on a breathing tube for more than 48 hours in the intensive care unit. Researchers will diagnose the syndrome by examining the tongue, using nasofibroscopy and ultrasonography. The study will also describe the clinical signs and paraclinical features of Tapia syndrome and identify factors associated with it. Participants will undergo clinical assessments including tongue examination, nasofibroscopy, and ultrasonography to evaluate nerve involvement and symptoms. The study will monitor patients for an average of two years to assess the prevalence of Tapia syndrome. Researchers will collect information about swallowing and speaking difficulties, nerve function, and other related features. Safety and informed consent are ensured throughout the study.
Actively Recruiting
Radiotherapy for head and neck cancers increases the risk of swallowing disorders, which can negatively impact nutrition, quality of life, and overall health, leading to higher hospitalization and mortality rates. Early intervention is important and requires precise assessment tools to predict swallowing difficulties, identify affected structures, and guide targeted rehabilitation. Current clinical exams lack precision, and existing complementary methods like videofluoroscopy or fiberoptic endoscopic evaluation are invasive, expose patients to radiation, require many resources, and have unknown prognostic value. Ultrasound imaging offers a non-invasive way to evaluate the morphology and movement of swallowing-related structures such as the tongue, hyoid bone, and suprahyoid muscles. This study plans to develop and assess an ultrasound-based predictive model for swallowing disorders during radiotherapy for head and neck cancer. Ultrasound exams will be done before treatment, and after 7 and 14 days, with blinded operators performing the assessments. Weekly clinical and swallowing tests will also be done by speech therapists, with videofluoroscopy if swallowing disorders are suspected. Participants will include 124 outpatients undergoing radiotherapy over 18 months. Researchers will collect demographic, clinical, ultrasound, and videofluoroscopy data, and monitor patients monthly. They will evaluate how well ultrasound markers predict swallowing disorders and undernutrition, assess measurement reliability, and relate ultrasound findings to quality of life. The primary outcome is the ability of ultrasound to predict swallowing disorders on the first day of radiotherapy. Data analysis includes Cox models and logistic regression to develop predictive scores and assess accuracy, sensitivity, and specificity.
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.