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Found 19 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying patients with metastatic colorectal cancer (mCRC) who have a specific BRAFV600E mutation. This rare subtype of mCRC has poor prognosis and resistance to current treatments, especially in tumors with microsatellite stability or proficient mismatch repair. The study aims to collect detailed clinical data and biological samples to better understand treatment outcomes, resistance, and survival in real-world settings. Participants will provide blood samples and tumor tissue samples to support various research goals. The study will evaluate circulating tumor DNA during different lines of metastatic treatment to predict treatment response and resistance. It will also analyze the immune environment of BRAFV600E mCRC tumors and study specific subgroups with mismatch repair deficiencies. Clinical management data will be collected to inform future therapeutic approaches. During the study, patients will be monitored regularly with blood sample collections of 30 mL at each time point. Researchers will gather information about treatments, survival, and biological markers over time. The main outcome measured is overall survival from diagnosis up to five years. Patients must be able to comply with study procedures and provide informed consent. The study aims to improve knowledge of this aggressive cancer subtype and support development of new treatments.
Actively Recruiting
Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.
Actively Recruiting
Researchers are studying adults with community-acquired pneumonia who need oxygen therapy due to acute respiratory failure meeting acute respiratory distress syndrome (ARDS) criteria. This condition often leads to tracheal intubation and poor outcomes. Previous studies showed that prone positioning reduces mortality in invasively ventilated ARDS patients and improves oxygenation in non-intubated patients with viral pneumonia, including COVID-19 cases. This trial focuses on patients with non-COVID community-acquired pneumonia using nasal high flow therapy, aiming to see if awake prone positioning can reduce the need for intubation and related treatments like sedation and muscle relaxation. Participants will be encouraged to spend as much time as possible in the prone position, ideally 4 to 8 hours per session, with a goal of up to 16 hours or more within each 24-hour period, depending on their tolerance. This intervention is compared to usual care without prone positioning. The study excludes patients with recent COVID-19 infection or those requiring immediate intubation. During the study, researchers will monitor patients for up to 28 days after randomization, focusing on whether they require intubation. Participants will be admitted to an intensive care or intermediate care unit, and their oxygen levels will be closely assessed using the PaO2/FiO2 ratio or equivalent SpO2/FiO2 measurements. Consent and social security affiliation are required. Safety and effectiveness of awake prone positioning in reducing intubation needs will be evaluated throughout the study period.
Actively Recruiting
Atrial fibrillation (AF) is the most common heart rhythm problem seen in medical practice and is responsible for 15% of all strokes and over 30% of strokes in people older than 65. Research suggests that 30 to 40% of isolated atrial fibrillations may run in families, involving about 40 genes that could contribute to both AF and stroke risk. Despite extensive study, the underlying causes of AF are not fully understood, and this study aims to identify genetic factors that may help find better treatments. Participants will provide blood samples for clinical data, DNA, and plasma collection to create a biological database. This database will support research into the genetic causes and blood clotting processes linked to AF and stroke. Blood samples will be collected and stored, with quality monitored on the day of collection and throughout a seven-year storage period. During the study, researchers will assess the quality of DNA and plasma samples collected. Participants' medical history related to AF and stroke will be considered, and their consent is required. The study involves long-term preservation of samples to support ongoing genetic and clinical research into AF and stroke. The overall participation duration includes the initial sample collection and extended monitoring of sample quality over seven years.
Actively Recruiting
This research aims to reduce extubation failure in critically ill patients with severe brain injuries who have ongoing impaired consciousness. These patients require mechanical ventilation through tracheal intubation after acute neurological injury. Because of residual neurological problems affecting airway control, extubation failure is common, and current guidelines for ventilator weaning exclude these patients. A clinical score developed in 2017 uses four neurological and airway reflex elements to predict extubation success with good accuracy. The study compares two approaches to extubation readiness after patients have passed a spontaneous breathing trial. In the intervention group, clinicians use the clinical score to decide if extubation should proceed when the score is above 9. In the control group, extubation is done according to usual care practices. Eligibility for the spontaneous breathing trial is assessed daily, and patients must have residual impaired consciousness and meet other criteria. The study uses a stepped wedge cluster randomized design involving intensive care units. Participants will be monitored from extubation through five days afterward to assess extubation failure. Researchers will measure whether using the clinical score improves timing and success of extubation compared to standard care. The study involves detailed neurological assessments and daily evaluations during the weaning process. The total study involvement includes screening, intervention with extubation decisions, and monitoring of respiratory outcomes within this critical care setting.
Actively Recruiting
Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.
Actively Recruiting
Cervical pseudarthrosis is a common complication after cervical spine surgery, affecting 3 to 15% of patients depending on individual factors and surgical details. Diagnosing this condition is challenging due to non-specific symptoms and limitations in current imaging methods. While CT scans provide detailed anatomical information, they do not fully capture the functional status of bone healing, and traditional radiographic techniques lack sensitivity and reproducibility. Bone scintigraphy, a functional imaging method, has been limited in use by poor spatial resolution but may offer new diagnostic insights when combined with hybrid imaging technology. This research evaluates the use of bone scintigraphy alongside standard CT scans to better diagnose cervical pseudarthrosis. Bone scintigraphy exams will be performed in addition to the CT scans already used in routine care. The study aims to assess the sensitivity, specificity, and predictive value of bone scintigraphy compared to the current reference method over a 12-month period. Participants will be patients over 21 years old who have previously undergone cervical arthrodesis and are being treated at specific clinics. They will undergo clinical evaluations including the Neck Disability Index score, as well as imaging tests. Researchers will monitor diagnostic accuracy and safety through these assessments over one year. Participation includes follow-up visits and imaging procedures to track the presence and diagnosis of cervical pseudarthrosis.
Actively Recruiting
Researchers are conducting a phase 3, multicenter, open-label, randomized study to evaluate new treatments for adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation (ASCT). The study aims to compare the effectiveness and safety of a combination of elranatamab and lenalidomide as a replacement for standard chemotherapy during the consolidation phase, and to assess elranatamab alone versus standard care during maintenance therapy. Participants will first receive standard induction therapy with four cycles of a drug combination called D-VRd. After this, they will be randomly assigned to either receive standard consolidation therapy involving high-dose chemotherapy and ASCT followed by D-VRd consolidation (Arm A), or elranatamab combined with lenalidomide for consolidation (Arm B). Upon completing consolidation, patients will be re-randomized to receive maintenance treatment with either lenalidomide alone (Arm C) or elranatamab alone (Arm D). During the study, participants will be monitored for treatment effects including minimal residual disease negativity at the end of consolidation, progression-free survival, and overall survival. The study involves various assessments including clinical evaluations, laboratory tests, and monitoring for disease progression or side effects. The entire treatment and follow-up period may last up to several years, allowing researchers to evaluate long-term outcomes and safety.
Actively Recruiting
Researchers are evaluating a paramedical training program for nurses and nursing assistants aimed at improving care for elderly patients aged 75 years and older hospitalized in specialist wards. The study focuses on preventing hospital-related complications (iatrogenesis) and reducing the length of hospital stay, which tends to increase with age. This research is inspired by successful American programs that enhanced geriatric care by training nursing staff, and it aims to adapt these approaches to the French healthcare context. The intervention involves training nurses and nursing assistants using a model similar to hygiene correspondents, supported by Geriatric Mobile Teams (GMT). The GMTs coordinate and support this training to disseminate good geriatric practices systematically. This approach builds on previous programs that emphasized the role of nursing staff in reducing complications like hospital confusion among elderly patients. Participants will be monitored for the length of their hospital stay, calculated from admission to discharge, up to one month. The study will also assess the prevention of hospital-related complications through this training approach. Eligible patients will be tracked during their hospital stay, and researchers will use medical records to measure outcomes. The total participation duration corresponds to the patient’s hospital stay within the study period.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating how a special protocol for announcing decisions to withhold or withdraw life-sustaining treatments affects the stress experienced by families in emergency departments. This study focuses on families receiving such difficult news in emergency settings, where time is limited and conditions are often not ideal for these announcements. Because these situations can cause significant anxiety and post-traumatic stress, the study aims to see if training emergency staff using a structured protocol and involving family partners can reduce this stress. The study involves training emergency department professionals using the DISCUSS announcement protocol. Emergency departments are grouped into clusters that will switch from usual care to the trained protocol in five phases, each lasting four months. Professionals trained under this protocol will deliver the decisions to withhold or withdraw life-sustaining treatments to families. The training includes both simulation center sessions and in situ practice, with partner families participating to help improve communication skills. Participants include family members or trusted persons present during the initial announcement of treatment decisions and caregivers working in the participating emergency wards. The study will assess family stress and symptoms of post-traumatic stress 90 days after the announcement. Data collection includes interviews and consent for voice recording. The goal is to measure how the new announcement protocol impacts family stress and psychological outcomes following these challenging discussions in the emergency department.
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