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Found 5 Actively Recruiting clinical trials
Actively Recruiting
The trial investigates spinal conditions such as spinal stenosis and spondylolisthesis, focusing on reducing the need for lumbar fusion surgery. It evaluates the use of endoscopic techniques for decompressing the lumbar spine, aiming to preserve its natural stability and function. This approach is considered a less invasive alternative to traditional surgical methods, with the hypothesis that it can lower the frequency of more extensive spinal fusion procedures. The study centers on endoscopic decompression procedures as a treatment option for patients with specific lumbar spine pathologies. These minimally invasive surgeries are designed to be optimized and cause less tissue damage. Participants are patients who have spinal conditions requiring surgical intervention, including those with complications such as lumbar scoliosis or degenerative spondylolisthesis. The endoscopic approach is assessed as a potentially effective way to avoid lumbar arthrodesis. Participants will be monitored primarily for the need for any additional surgical interventions within one year after treatment. The study involves evaluations using preoperative imaging, such as radiographs and MRI, to classify spinal abnormalities and determine eligibility. Safety and outcomes are tracked over the course of a year to understand the effectiveness of the endoscopic procedures in reducing the requirement for further surgery.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of GLSI-100 immunotherapy in people with HER2/neu positive breast cancer who are at high risk of the cancer coming back. This Phase 3 study focuses on individuals who have completed both neoadjuvant and postoperative adjuvant standard treatments, including trastuzumab-based therapy. The study includes participants who are HLA-A*02 positive, with an additional open-label arm for non-HLA-A*02 positive subjects, aiming to understand how this immunotherapy may help prevent invasive breast cancer recurrence. Participants receive treatment through a series of injections: six intradermal injections as the Primary Immunization Series over the first six months, followed by five booster injections given every six months. One group receives the investigational GLSI-100, which contains GP2 and GM-CSF, while a control group receives placebo injections containing normal saline. The open-label arm explores the treatment in non-HLA-A*02 positive subjects. Throughout the study, participants are monitored for invasive breast cancer-free survival over a median follow-up of four years, with interim analyses planned. Assessments include clinical evaluations to confirm no residual or persistent breast cancer, organ function tests, and pregnancy tests. Safety and efficacy data are collected to understand the treatment's impact, with participants followed closely during and after the treatment period to track outcomes and side effects.
Actively Recruiting
Researchers are investigating treatments for locally advanced anal squamous cell carcinoma, a rare but increasing cancer often linked to human papillomavirus (HPV). The study compares standard chemoradiotherapy, which combines radiation and chemotherapy with 5FU and mitomycin-C, to a new approach adding induction chemotherapy (modified DCF protocol) before the standard chemoradiotherapy. This randomized phase 3 trial aims to improve disease-related event-free survival and other outcomes such as overall survival, colostomy-free survival, treatment tolerability, response rate, and quality of life in patients with T3-T4 or N1 stage anal cancer without metastasis. Participants in the experimental group receive four cycles of induction chemotherapy (docetaxel, cisplatin, and 5-FU given every two weeks), followed by standard chemoradiotherapy consisting of 33 sessions of radiation over 6.5 weeks combined with mitomycin during weeks 1 and 5 and capecitabine taken on radiation days. The control group receives only the standard chemoradiotherapy. Radiation is delivered using intensity-modulated external irradiation (IMRT-SIB) targeting the pelvis and tumor area with specified doses. During the study, patients undergo follow-up visits starting 8 weeks after treatment, then every 4 months for two years, and every 6 months for a final year. Follow-up includes clinical exams and imaging tests such as CT and MRI. The study measures disease-related event-free survival at 2 years after treatment completion as the primary outcome. Participants must be adults aged 18 or older with measurable tumors on MRI and able to receive chemotherapy and radiotherapy, with additional health criteria assessed before enrollment.
Actively Recruiting
This research aims to observe patients in France who have HER2-negative early breast cancer and are treated with olaparib. The study focuses on understanding how many patients complete the full planned course of olaparib treatment, which is given as adjuvant therapy following initial cancer treatment. It is a national, multicenter, prospective cohort study conducted without altering the usual care provided by doctors. Patients enrolled will be those starting adjuvant olaparib treatment based on their doctor's decision. There are no experimental interventions or treatment changes imposed by the study. The study captures real-world use of olaparib across multiple centers in France. Participants will be followed for at least 18 months after joining the study to see if they complete the full duration of olaparib treatment. Researchers will collect data on treatment adherence and other relevant clinical information during this period. The main outcome measured is the proportion of patients who receive olaparib for the entire planned treatment period.
Actively Recruiting
This research aims to evaluate whether adding a digital telemonitoring platform called "CUREETY TECHCARE" to the usual care can improve outcomes for patients with metastatic triple-negative breast cancer who have not received prior treatment and are starting first-line systemic therapy. The study focuses on whether the telemonitoring platform can improve patients' quality of life, reduce hospitalizations, and increase overall survival compared to standard care alone. Participants in the telemonitoring group will use the Cureety platform weekly to complete questionnaires tailored to their treatment. Responses are analyzed by an algorithm that classifies their health status into risk categories, which guide medical staff in monitoring and managing patient care. The medical team uses a dashboard to track patients daily, respond to alerts, and adjust treatments as needed while providing support during standard care consultations. Patients receive messages with advice based on their condition classification. Throughout the study, patients will have their quality of life measured every three months up to 24 months, and researchers will track hospital-free survival and overall survival from the time of randomization up to 24 months. Patients will need to complete web-based questionnaires and have access to internet-connected devices for telemonitoring. The study will monitor safety and treatment effects during this period to understand the benefits of telemonitoring alongside standard care.