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Found 8 Actively Recruiting clinical trials
Actively Recruiting
Non-muscle-invasive bladder cancer NMIBC is a type of bladder tumor that affects the inner lining of the bladder without invading the muscle layer. This research aims to collect and analyze real-world data on how NMIBC is managed and followed up in clinical practice across France. The study seeks to assess the performance of urine tests used to detect tumor recurrence and to understand variations in treatment and patient outcomes. The study is observational and involves collecting medical data from patients being monitored for NMIBC, including results from urine biomarker tests done before biopsies or resections. Urologists participating in the French Urology Association will record findings from regular bladder endoscopic exams and urine test results during routine care visits. Data analysis will focus on the accuracy of urine tests in predicting tumor recurrence and how this varies by tumor characteristics and prior treatments. Participants will have their medical history, treatments, and urine test results entered into a registry at enrollment. During follow-up visits scheduled as part of their personalized care, data on bladder exams and urine tests will be collected. Researchers will evaluate outcomes such as recurrence-free survival and the diagnostic value of urine biomarkers over a five-year period. The study plans to include around 8,000 patients over six years to improve understanding of NMIBC management and follow-up.
Actively Recruiting
Degenerative Lumbar Spinal Stenosis LSS is a common condition affecting over 102 million people annually. It involves narrowing of the spinal canal in the lower back, causing pain and leg problems. When symptoms worsen despite medical treatment, surgery is recommended. This study compares the B-Dyn dynamic stabilization device with conventional rigid fusion surgery to see if B-Dyn can maintain function and mobility better after surgery and reduce degeneration of adjacent spine segments. Participants will receive either the B-Dyn device or conventional bolted fusion with or without a cage during surgery under general anesthesia. The B-Dyn device stabilizes the operated area while preserving some mobility, using screws and a movable rod. Conventional fusion connects screws rigidly to stabilize the spine segment. The study lasts 60 months with a 56-month inclusion period to enroll about 216 patients. During the study, participants will have regular assessments including disability questionnaires Oswestry Disability Index, pain scales, quality of life surveys, anxiety evaluations, X-rays, MRI scans, and walking tests at multiple timepoints up to 60 months after surgery. Researchers will monitor safety, device tolerance, mobility preservation, and complications such as adjacent segment degeneration. The primary outcome is the degree of functional disability related to low back pain at 12 months post-surgery.
Actively Recruiting
This research aims to evaluate the effectiveness of fundoplication with the stomach excluded in reducing severe gastroesophageal reflux that requires surgery in patients who have previously undergone one anastomosis gastric bypass. The study focuses on adults who experience disabling reflux after this type of gastric bypass and seeks to provide a thorough and objective assessment of reflux suppression. It is designed as a single-center, interventional, non-randomized pilot study conducted at one site. Participants will have undergone one anastomosis gastric bypass surgery followed by fundoplication of the excluded stomach specifically to treat disabling gastroesophageal reflux that has not responded to medical treatment and requires surgical intervention. This procedure is the main intervention being evaluated. The study includes patients treated within two years prior to enrollment, and the intervention aims at reflux suppression in this particular surgical context. Throughout the study, participants will undergo objective evaluations including gastrojejunal fibroscopy, ph-impedancemetry, and abdominal CT scans to assess reflux disease. Quality-of-life questionnaires will be completed, and pregnancy tests or contraception use will be monitored for women of childbearing age. The primary outcome measured is the response rate following fundoplication over a 2-year period. Participants will be followed until the study ends in December 2026, with assessments to evaluate reflux control and safety.
Actively Recruiting
Researchers are investigating the best noninvasive respiratory support method for patients in intensive care units ICUs who develop respiratory failure after planned removal of their breathing tube extubation. This condition affects about 20% of ICU patients, and many require reintubation, which is linked to high mortality rates. The study aims to compare whether alternating non-invasive ventilation NIV with high-flow nasal oxygen reduces death rates compared to high-flow nasal oxygen alone in these patients. The trial is a multicenter, randomized, controlled study where patients with post-extubation respiratory failure are assigned to one of two groups. One group receives continuous high-flow nasal oxygen treatment for 48 hours, while the other group receives NIV alternating with high-flow nasal oxygen during the same period. NIV involves pressure-support breathing with specific settings to help patients breathe, and the study ensures balance in patient groups based on carbon dioxide levels in the blood. Participants will be closely monitored with assessments including timing of death, reintubation events, days without ventilator use, length of ICU and hospital stay, and mortality at different time points up to 90 days. The main outcome measured is death rate 28 days after respiratory failure onset. The study includes clinical evaluations and blood gas tests to guide treatments and decisions. Participation duration includes the initial 48-hour treatment period and follow-up assessments extending to 90 days.
Actively Recruiting
This research focuses on adults undergoing surgery for rotator cuff tendinopathy and aims to understand how preoperative stress levels might affect postoperative recovery. The study explores the hypothesis that higher stress before surgery could lead to more severe complications, such as complex regional pain syndrome or adhesive capsulitis, which can prolong recovery and impact personal and professional life. Participants in this observational study will be assessed using questionnaires, including the MSP9 score, Cungi scale, and EVA scale, to measure stress levels before surgery. The research centers on patients having first-line surgery for rotator cuff tendinopathy, with no active treatment interventions being administered as part of the study. Throughout the study, participants will undergo stress assessments before surgery using established scales. Researchers will track stress levels to evaluate their association with postoperative outcomes. The main measurement is the preoperative MSP9 stress score, with data collection completed by September 2026. Participants usual care continues uninterrupted during the study.
Actively Recruiting
Researchers are conducting an observational study to evaluate the recurrence rate of pilonidal sinus after laser treatment in adult patients who need this procedure. The study focuses on whether a clinical recurrence, defined as the presence of a fistula in the intergluteal cleft, occurs within two years following the laser treatment. This study enrolled patients undergoing surgery as part of their usual medical care for pilonidal sinus, including those with any type or recurrence after previous treatments. Participants included in this study are those requiring laser surgery for pilonidal sinus. The study does not involve additional interventions or randomization but follows patients prospectively to monitor outcomes after their standard laser treatment. Participants will be surveyed at 1 and 2 years post-procedure to assess for recurrence. During the study, participants will complete survey questionnaires about their condition at 1 and 2 years after the laser surgery. Researchers will measure the primary outcome of clinical recurrence at 2 years post-operation. The study is observational and does not involve experimental treatments, focusing on long-term monitoring of recurrence following routine care, with participation expected to last for at least two years.
Actively Recruiting
Researchers are studying the rate at which patients return to sports activities at least three years after receiving a total knee prosthesis. The study compares three different types of knee prosthesesmedial pivot, medial bearing, and cruciate retainingto understand how each design relates to patients return to sport. This observational study focuses on patients who had surgery between 2018 and 2020 and aims to gather detailed information about their sports activity post-surgery. The study involves three groups of patients, each having received one of the three types of knee prostheses mentioned. Patients are contacted by the investigator, informed about the study, and invited to participate. Participants complete questionnaires assessing their physical and functional abilities, which can be returned electronically or by phone. A secure email is created specifically for the study to manage communications and data collection. Participants will be assessed by telephone using various questionnaires on their physical and functional status. The main outcome measured is the rate of return to sport three years after surgery. The study includes a review of medical records and ongoing communication with patients to collect their questionnaire responses. This process helps researchers evaluate how well patients resume sports activities following the different prosthetic knee designs.
Actively Recruiting
Researchers are conducting an observational and prospective multicenter study to evaluate the long-term performance and safety over 10 years of ATF Implants and Lap Mdical devices used in total hip arthroplasty or hemiarthroplasty. The study aims to collect clinical evidence on the survival rate of these hip prostheses and assess their safety and performance during this period. It also seeks feedback on the surgical instruments used for implant placement. The study follows patients before and after their hip replacement surgery using implants made by ATF Implants and Lap Mdical. Surgeons evaluate patients based on standard orthopedic surgery criteria and record any complications or adverse effects observed. The main focus is on tracking the 10-year survival rate of the implants, while secondary goals include monitoring hip joint function at multiple points before surgery, and at 6 months, 2, 5, 7, and 10 years after surgery. Participants will be followed over a 10-year period with regular assessments by the surgical team. These evaluations include clinical examinations and monitoring for any complications related to the implants or surgical instruments. The study gathers detailed data on hip joint performance and safety, helping to understand how well the implants work and last over a decade. This long-term follow-up provides important information for future patients and healthcare providers.