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Found 5 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Swallowing disorders are common in intensive care unit ICU patients, especially those with tracheostomies that can cause changes affecting swallowing. These disorders are linked to serious problems like respiratory issues, poor nutrition, and even death. Current clinical exams lack precision, while existing tests like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing FEES are invasive, resource-heavy, and hard to access. Researchers are exploring ultrasound imaging as a non-invasive and precise method to assess swallowing disorders in difficult-to-wean tracheostomised ICU patients. This observational study will enroll 119 difficult-to-wean tracheostomised patients over nineteen months at multiple hospitals. Each patient will undergo FEES and ultrasound evaluations within a two-hour window. Ultrasound will assess movements and structures including the tongue, larynx, and suprahyoid muscles. The ultrasonographer will be blinded to other assessments. The goal is to develop a diagnostic ultrasound model using selected variables, which will be transformed into an easy-to-use scoring system to predict swallowing disorders. Participants will be assessed through clinical data collection and swallowing tests. Ultrasound exams will measure features like tongue thickness and muscle contractions, while FEES will evaluate swallowing function and residue severity. Reliability tests will be done with multiple examiners. Researchers will analyze data statistically to create and validate the ultrasound scores accuracy and reliability. The study aims to improve early detection and management of swallowing disorders non-invasively, over the course of the study period ending in April 2026.

Age: 18Years +All Genders
4 locations
E

Actively Recruiting

Researchers are studying the impact of remote therapeutic cooking workshops on adults living with obesity to see if these workshops can improve dietary balance. This multicenter, open-label, controlled study uses a stepped wedge cluster design to compare two types of cooking workshopsclassic recipe-based and culinary challengesalongside usual care. The goal is to assess changes in diet quality, including fruit and vegetable intake, cooking frequency, and reduced consumption of ultra-processed foods, based on the latest national nutrition recommendations. Participants receive either usual care alone, usual care plus six classic cooking workshops led by a dietician, or usual care plus six culinary challenge workshops where participants create recipes. The study is conducted across six hospitals and involves completing questionnaires about eating habits and self-efficacy. The interventions are delivered remotely through videoconferencing to allow cooking in participants own kitchens. During the study, participants daily diet will be evaluated after three months, with additional assessments of self-efficacy, personal goals, and body mass index at three and six months. Participants must have the tools and connectivity for video workshops and will complete questionnaires on their eating habits and confidence in cooking. The total study period includes baseline assessments, interventions over several weeks, and follow-ups to monitor the effects on dietary behavior and weight management.

Age: 18Years - 75YearsAll GendersPhase Not Applicable
6 locations
S

Actively Recruiting

Tapia syndrome is a rare condition involving damage to the recurrent and hypoglossal nerves, leading to paralysis of one vocal cord and the same-side half of the tongue. It usually causes voice changes and swallowing difficulties, and is often unilateral but can be bilateral. This study aims to determine how common Tapia syndrome is among patients admitted to a weaning unit after prolonged intubation in the ICU, as well as to describe its clinical and paraclinical features and identify associated risk factors. The study is observational and includes patients who stayed in the ICU with orotracheal intubation lasting longer than 48 hours. Participants are grouped based on whether they have Tapia syndrome or not. Diagnosis involves a lingual clinical exam, nasofibroscopy, and ultrasound. The study tracks clinical signs such as tongue and soft palate involvement, voice impairment, and swallowing disorders. Participants will be evaluated through clinical exams and diagnostic tests following initial swallowing assessments within a week. Researchers will monitor symptoms like dysphonia and dysphagia and use imaging tools like nasofibroscopy and ultrasound to assess nerve involvement. The main outcome is the prevalence of Tapia syndrome measured over about two years. The study also looks at factors linked to the syndrome and collects data during the inclusion day and afterward to understand its features and impact.

Age: 18Years +All Genders
1 location
N

Actively Recruiting

Researchers are studying patients with metastatic colorectal cancer to identify clinical and biological factors that predict how well fruquintinib works in real-world settings. The study aims to confirm survival and safety results seen in previous trials and to better understand treatment outcomes, especially in older patients aged 70 and above, who have been underrepresented in earlier research. This cohort is designed to optimize treatment pathways by pinpointing patients who may benefit most from fruquintinib. Participants will receive fruquintinib, an oral drug that targets specific blood vessel growth receptors, given as 5 mg daily for 21 days followed by a 7-day break. This cycle repeats until the cancer progresses, unacceptable side effects occur, the patient dies, or the patient chooses to stop treatment. The study includes patients treated under compassionate use or after marketing authorization in France, integrating routine clinical practice data. During the study, participants will be monitored for overall survival up to one year after starting treatment, which is the main outcome measured. Additional monitoring includes progression-free survival within the same timeframe. The study involves collecting biological samples like circulating tumor DNA and tumor tissue blocks. Safety, survival, and treatment response data will be gathered to support understanding of fruquintinibs effects in everyday clinical use. The study is expected to continue until the end of 2031.

Age: 18Years +All GendersPhase Not Applicable
83 locations
U

Actively Recruiting

Radiotherapy for head and neck cancers increases the risk of swallowing disorders, which can negatively affect nutrition, quality of life, and overall health, leading to more hospitalizations and higher mortality. This research aims to evaluate an ultrasound-based predictive model to detect the risk of swallowing disorders during radiotherapy. The study will assess the accuracy and reliability of ultrasound markers compared to current methods, which are often invasive, irradiating, and hard to access. The study will involve 124 outpatients starting radiotherapy for head and neck cancer at Forcilless Hospital over eighteen months. Participants will undergo three ultrasound examinations before treatment and after seven and fourteen days, performed by blinded ultrasonographers. Weekly clinical swallowing assessments will be done by speech-language therapists, with videofluoroscopy used when swallowing disorders are suspected. The study will analyze ultrasound measurements of structures involved in swallowing, such as the tongue and suprahyoid muscles, to develop and validate a predictive model. Participants will be monitored throughout their radiotherapy treatment, with data collected on swallowing function and nutritional status. Assessments include clinical evaluations, ultrasound exams, and videofluoroscopy when needed. Ultrasound measurement reliability will be tested with inter- and intra-operator evaluations. The main outcome is the ability of ultrasound markers to predict swallowing disorders during treatment. Safety and data accuracy will be overseen through monthly monitoring, with participation lasting the duration of radiotherapy plus minimal additional time for assessments.

Age: 18Years +All Genders
1 location