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Found 11 Actively Recruiting clinical trials
Actively Recruiting
Researchers are conducting a prospective, multicenter cohort study to follow children with idiopathic nephrotic syndrome INS, a rare kidney disease. The study aims to collect data on pediatric patients treated by pediatric nephrologists in France and its overseas territories to better understand the diseases characteristics and support future clinical trials. The study involves regularly recording medical, biological, psychological, and social data through routine clinical follow-ups, hospitalizations, and consultations. Additionally, annual telephone interviews will be conducted for patients in remission. Quality of life, treatment adherence, and treatment impact questionnaires will also be collected. A biobank is established to collect blood, urine, hair, and nail samples at the disease onset before immunosuppressive treatment begins. Participants will be followed from disease onset until age 18 or transfer to adult nephrology care. Data is collected via a secure website, medically validated and entered by clinical research staff. The main outcome is the number of cases included and their characteristics over two years. Participation involves routine care visits, interviews, and questionnaires, with continued monitoring planned through the study period ending in 2048.
Actively Recruiting
Researchers are studying prostate cancer patients undergoing radical prostatectomy to compare three surgical methods robot-assisted laparoscopy, conventional laparoscopy, and laparotomy. The study aims to evaluate the impact of these techniques on urinary and erectile functions, as well as their cost-effectiveness and long-term outcomes. This large, multicenter prospective observational study responds to previous concerns about the lack of high-quality evidence for robot-assisted surgery in prostate cancer treatment. Participants will undergo one of the three prostatectomy procedures robot-assisted laparoscopy, conventional laparoscopy, or laparotomy. Urinary and erectile functions will be assessed before and after surgery using standardized scores like the EPIC 50 and the International Index of Erectile Function IIEF-5. Outcomes including urinary incontinence, erectile dysfunction, and prostate-specific antigen PSA levels will be followed for up to five years. Cost-effectiveness will be evaluated at 12 months using the EQ5d-5L score. Throughout the study, participants will be evaluated at multiple time points, including 45 days and up to five years after surgery, to monitor urinary and erectile functions and other prostatectomy-related effects. Assessments involve questionnaires and clinical measurements. This comprehensive follow-up is designed to help determine the benefits and risks of each surgical approach, supporting informed decisions for patients and healthcare authorities. The study excludes patients without French health insurance or those unable to consent, focusing on adult males scheduled for prostatectomy.
Actively Recruiting
This research focuses on adult patients diagnosed with idiopathic retroperitoneal fibrosis IRF to study the early discontinuation of steroid treatment in patients with negative FDG-PETCT scans. The study is a prospective multicenter cohort design assessing the effects of prednisone administered orally for 9 to 21 months. It aims to better understand IRF relapse rates after stopping steroids and the role of FDG-PETCT imaging in disease activity. Patients with positive FDG-PETCT scans receive oral prednisone at a starting dose of 1 mgkgday for one month, followed by a tapering schedule to reduce the dose below 10 mgday by six months and below 7.5 mgday by nine months. Those with negative FDG-PETCT results are excluded from the study. Follow-up visits are scheduled at 6, 9, 12, 15, and 21 months, with additional visits if relapse occurs. Treatment continuation or discontinuation after nine months depends on remission status and imaging results. Participants undergo clinical exams, blood and urine tests, abdominal CT scans, and FDG-PETCT imaging at baseline and during follow-ups. Researchers monitor symptoms, medication adherence, adverse events, and disease progression. The primary outcome is the cumulative IRF relapse rate 12 months after stopping steroids. The study includes safety assessments and analyzes changes in disease hypermetabolism over time, lasting until November 2028.
Actively Recruiting
Researchers are evaluating whether the EMOCARE emotional monitoring software provides consistent results compared to standard questionnaires used to assess emotional states in patients with mild to moderately severe depressive episodes. This study aims to understand how well EMOCARE matches tools like PHQ-9, MADRS, GAD-7, BDI-II, and EQ-5D-5L, and to learn about any medical issues participants may experience when using this passive monitoring software. The study focuses on outpatients with major depressive disorder who use digital devices regularly. Participants will install the EMOCARE software on a smartphone, computer, or similar device and can activate or deactivate it during a six-week follow-up period. They will attend two scheduled visits at the centerone at the start and one six weeks laterto complete questionnaires and be interviewed by a doctor. Additionally, participants will complete questionnaires independently at home two and four weeks after the first appointment. A phone call from the doctor will take place three weeks after the initial visit to check on how participants are feeling. Participants will also keep a diary of symptoms, medical consultations, and any medication changes. Throughout the study, researchers will collect and compare scores from EMOCARE and various questionnaires at multiple time points, including baseline, two, four, and six weeks. They will monitor the acceptability of the device, adverse events, and changes in depression severity. The main outcomes measured are changes in EMOCARE scores and PHQ-9 scores from baseline to six weeks. The total participation duration is six weeks, with regular monitoring and assessments to understand emotional states and device use.
Actively Recruiting
Squamous cell carcinoma of the anus is a rare but increasingly common cancer, often linked to human papillomavirus HPV. For early-stage tumors, combined radiotherapy and chemotherapy with 5FU and mitomycin-C provide good outcomes, but advanced tumors have a poor prognosis with a high relapse rate. Researchers are studying a new approach combining induction chemotherapy with docetaxel, cisplatin, and 5FU mDCF followed by standard chemoradiotherapy to improve treatment results for locally advanced anal cancer T3-4 or N1. This is a randomized phase 3 trial comparing this new strategy to the current standard treatment. The study includes two groups one receives the usual chemoradiotherapy, which involves 33 radiotherapy sessions over 6.5 weeks combined with mitomycin-C and capecitabine chemotherapy taken on radiotherapy days. The other group starts with 4 cycles of mDCF chemotherapy given every two weeks before receiving the same chemoradiotherapy as the control group. Radiotherapy uses intensity-modulated external irradiation with a targeted boost to the tumor and involved lymph nodes. Participants will be followed after treatment with check-ups at 8 weeks, then every 4 months for two years, and every 6 months in the third year. Follow-up includes clinical exams and imaging scans CT and MRI. The main measure of success is disease-related event-free survival two years after treatment. Other outcomes include overall survival, colostomy-free survival, treatment side effects, tumor response, and quality of life. The total study duration for each participant may extend over several years including this follow-up period.
Actively Recruiting
This research aims to understand the frequency of pulmonary embolism, a blood clot in the lungs, in patients with acute heart failure, a condition where the heart struggles to pump blood effectively. These two conditions share symptoms like sudden shortness of breath, making pulmonary embolism hard to detect in heart failure patients. The study investigates whether systematically testing for pulmonary embolism improves diagnosis and patient care compared to usual practice, where testing is done case by case. Participants will be admitted to hospitals with recent or worsening breathing problems and signs of acute heart failure. In some hospitals, doctors will use a step-by-step screening method involving clinical scores, blood tests for D-dimer, ultrasound scans, and CT scans to detect pulmonary embolism within 48 hours of admission. In other hospitals, doctors will follow their usual approach without systematic testing. Researchers will compare these two approaches to see how often pulmonary embolism is found and how patient outcomes differ. During the hospital stay and for three months afterward, participants will be monitored for survival, new blood clots, bleeding events, repeat hospital visits, and total hospital days. Information about symptoms, tests, diagnoses, and treatments will be collected. This monitoring aims to provide a clearer understanding of pulmonary embolism rates and whether systematic screening leads to earlier detection and better care, potentially reducing complications or deaths related to missed diagnoses.
Actively Recruiting
This research aims to observe patients in France with HER2-negative early breast cancer who are treated with olaparib, a medication chosen by their doctors. The study focuses on understanding how often patients complete the full course of olaparib treatment and gathers information on related genetic factors and medical history. It is a national, multicenter, prospective observational study without experimental treatment assignment. Participants in this study receive adjuvant olaparib treatment as part of their usual care under their physicians discretion. The study does not assign treatments but follows patients who start olaparib, tracking their treatment progress for up to 18 months after inclusion. There are no additional interventions or placebo groups. Throughout the study, researchers collect data on treatment completion rates, types of BRCA mutations, variant types, medical history, and the time until olaparib treatment stops. Participation involves observational follow-up, with no extra treatment visits beyond routine care. The overall participation lasts 18 months after a patients enrollment, focusing on real-world treatment experiences and outcomes.
Actively Recruiting
Lower limb trauma that requires immobilization is common and raises the risk of venous thromboembolism VTE. The TRiPcast score helps identify patients at high risk score 7 who need preventive anticoagulant treatment. While low molecular weight heparins LMWH are standard, recent studies suggest they may not fully prevent VTE in high-risk patients. This trial compares rivaroxaban, a direct oral anticoagulant, with LMWH to assess which is more effective and easier to use for preventing blood clots in these patients. Participants with lower limb trauma and a TRiPcast score of 7 or higher are randomly assigned to receive either rivaroxaban 10 mg orally once daily or LMWH injections during the period of immobilization, until they can bear weight on the limb again. Treatment begins in the emergency department and continues at home, with dosing for LMWH following local guidelines and rivaroxaban fixed at 10 mg daily. Throughout the study, participants are monitored at 45 and 90 days after treatment start to track symptomatic blood clots and bleeding events. Their satisfaction with the treatment is also assessed. Researchers measure the rate of symptomatic venous thromboembolic events primarily at 45 days and evaluate safety, treatment satisfaction, and cost-effectiveness at 90 days. The total follow-up lasts up to 90 days to fully capture outcomes and treatment impact.
Actively Recruiting
Researchers are conducting a global, single-arm, non-controlled observational study to assess the long-term performance, safety, and usability of Teknimeds range of sports surgery products. These devices, including bioabsorbable interference screws, pins, non-absorbable sutures, and anchors, are commonly used in orthopedic surgeries such as knee ligament reconstructions, shoulder repairs, and foot surgeries. This study aims to collect real-world safety and efficacy data to better understand these products behavior over time. The study involves patients undergoing orthopedic surgeries using various Teknimed devices like EUROSCREW NG, ISOFIX, SUTURLINK, ALINKS, and bioresorbable pins. Patients include those having surgeries on knee anterior and posterior cruciate ligaments, ankle, shoulder, and foot. The study collects data both retrospectively from surgeries performed since January 2016 and prospectively from patients planned for surgery with these products. Treatments are delivered as part of standard orthopedic surgical procedures. Participants will be followed according to local medical care standards, with assessments including joint function evaluation for up to 4 years and adverse event monitoring for 5 years. Secondary measures include pain levels, pain medication use, patient satisfaction, quality of life, radiological outcomes, and device usability during surgery. Data collection occurs during routine follow-ups and includes retrospective and prospective clinical information, ensuring comprehensive long-term monitoring of these orthopedic devices.
Actively Recruiting
Researchers are investigating the use of a new polymer cerclage system called OrthoLoop in managing fractures of the femur and humerus bones, including those around prosthetic hips and shoulders. This study compares OrthoLoop to standard cerclage systems, mainly metallic ones, to see if it improves bone healing and reduces complications. The study focuses on adults aged 18 and older who require cerclage wiring as part of their fracture treatment. Participants receive either the OrthoLoop polymer cerclage device or a standard cerclage system after surgical repair of their fracture. The study is designed with two groups and follows patients for 36 months after surgery. Follow-up visits are scheduled at 6-8 weeks, 3 months, 6 months, and 36 months to monitor healing, pain, device performance, and any complications. During the study, researchers evaluate bone healing success six months after surgery, track the rate and timing of bone union, and observe any rupture or movement of the cerclage devices. Pain levels and surgical details are recorded at multiple intervals. The study also collects data on complications and surgeon satisfaction with the devices. This thorough follow-up aims to provide a detailed assessment of the OrthoLoop system compared to standard care over three years.
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