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Found 22 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the real-world effectiveness of deucravacitinib in adults diagnosed with moderate-to-severe plaque psoriasis. This observational study aims to understand how this treatment works outside of controlled clinical trials, focusing on health outcomes important to patients and doctors. It is sponsored by Bristol-Myers Squibb and conducted in France. Participants in this study have started treatment with deucravacitinib as prescribed by their doctors. The study observes these patients over time without altering their treatment plans. There are no placebo or comparison groups since this is an observational study that follows patients initiating deucravacitinib treatment. During the study, doctors will assess skin condition using the Physicians Global Assessment and measure quality of life with the Dermatology Life Quality Index at baseline and several points up to 24 months. Patients will also report symptoms like itch, skin pain, and fatigue using visual scales. Researchers will track how long patients remain on treatment and reasons for stopping. The study involves regular follow-ups at months 1, 4, 12, 18 optional, and 24 to gather this information.

Age: 18Years +All Genders
48 locations
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Actively Recruiting

Pemphigus diseases are serious, chronic autoimmune conditions that cause blistering due to the immune system attacking certain skin proteins. The two main types studied here are pemphigus vulgaris and pemphigus foliaceus. Researchers are evaluating a new personalized maintenance therapy involving rituximab infusions guided by antibody levels to see if this approach can better prevent disease relapses compared to the standard treatment. This is a phase 4 randomized study conducted by the University Hospital, Rouen, building on previous rituximab trials that led to regulatory approvals. Participants in the trial will receive initial treatment with rituximab and oral prednisone following French guidelines, with rituximab given at Day 1, Day 14, Month 12, and Month 18. One group will receive this standard regimen, while the experimental group will have their treatment adapted based on anti-desmoglein antibody levels. Additional rituximab infusions may be given at Month 6 or later if antibody levels remain high or increase, with up to two extra infusions per year allowed during the study. During the study, participants will be regularly monitored through blood tests for antibody levels and blood cells every three months for up to 7.5 years. Researchers will assess the number of disease relapses, time to relapse, duration of remission, quality of life, and rituximab exposure. The study will also track the total dose of rituximab and record safety outcomes. This long follow-up aims to understand if personalized maintenance with rituximab can reduce relapses and the need for corticosteroid treatment.

Age: 18Years - 80YearsAll GendersPhase 4
34 locations
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Actively Recruiting

This research aims to improve genetic counseling by classifying gene variants found in families with a history of hereditary cancers, especially breast and ovarian cancer. Initially focused on BRCA1 and BRCA2 genes, the study now includes multiple genes from a large French oncogenetics database, covering thousands of families and variants. The goal is to better understand which gene variants are linked to cancer risk and to refine how these variants are classified for clinical use. Participants include index cases carrying specific gene variants and their family members. The study collects saliva samples from relatives to test for the presence of these variants, particularly those classified as uncertain significance class 3, likely pathogenic class 4, or hypomorphic pathogenic class 5. Genetic analyses are performed by specialized laboratories, and data from multiple families is combined to assess how these variants co-segregate with cancer occurrence. Throughout the study, researchers analyze genetic data using statistical models to estimate the likelihood that certain variants cause cancer. They use anonymous results for overall variant classification and share findings with families when variants are found to be pathogenic. This helps guide genetic counseling, possible preventive measures, and clinical management. The study spans up to 15 years and continuously updates classification methods and clinical recommendations based on new data.

Age: 18Years +All GendersPhase Not Applicable
62 locations
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Actively Recruiting

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

Age: 18Years +All Genders
211 locations
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Actively Recruiting

This research focuses on women aged 18 to 65 with symptoms of acute cystitis without risk of complication. It aims to evaluate whether using a shared decision-making tool in pharmacies can help patients better understand the benefits and risks of taking antibiotics and adjust antibiotic use accordingly. The goal is to reduce unnecessary antibiotic prescriptions while still selecting patients who truly need treatment. Participants are divided into two groups. One group follows the standard French delegation protocol for acute cystitis management by pharmacists, which recommends systematic antibiotic therapy. The other group uses the same protocol supplemented with a shared decision-making tool to decide if antibiotics should be given based on patient preferences after being informed. This study compares antibiotic dispensing between these groups. After diagnosis and consent, patients receive care according to their group assignment. Researchers collect data on antibiotic prescriptions and patient demographics. Participants are followed up by phone 14 days later to assess antibiotic use, symptom impact using the Activity Impairment Assessment scale, satisfaction, decision confidence via the OConnor scale, and any medical visits. Antibiotic dispensing is tracked through national pharmacy records. The study runs from May 2026 to November 2026.

Age: 18Years - 65YearsFEMALEPhase Not Applicable
14 locations
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Actively Recruiting

Researchers are evaluating the impact of relaxing touch on the use of chemical restraint in patients who are sedated and intubated in intensive care. This randomized prospective study focuses on patients from the time sedation is lifted until they are extubated. The trial aims to understand whether touch relaxation can influence the need for chemical restraint in this critical care setting. Participants are randomly assigned to one of two groups. One group will receive no relaxing touch and acts as the control. The other group will receive relaxing touch therapy twice daily, consisting of 30-minute massages divided equally among the head, feet, and hands. This intervention is delivered during the intensive care stay, specifically between sedation lifting and extubation. During the study, researchers will monitor chemical restraint use over one year, along with occurrences of self-extubations. Patient discomfort, respiratory rate, and heart rate will be assessed at multiple time points within 90 minutes after the intervention. The study involves close follow-up to measure these outcomes and the ratio of chemical restraint use. The total duration includes assessments during the hospital stay and follow-up over the year.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

This research evaluates the diagnostic performance of a new Clinical Decision Support tool using fresh plasma samples in patients suspected of venous thromboembolism VTE, including pulmonary embolism PE and deep vein thrombosis DVT. It compares results from fresh plasma with those from frozen plasma and the current standard diagnostic strategy. The study includes various patient groups, such as those eligible for D-dimer testing, patients with high clinical probability, patients with conditions affecting D-dimer levels, those with recent thrombotic events, active cancer, or COVID-19. The study uses routine coagulation tests and the new Clinical Decision Support algorithm on both fresh and frozen plasma samples. The algorithm applies manual or machine learning methods to calculate exclusion scores based on D-dimer and fibrin formation assays. Participants receive standard care and diagnosis according to usual practice while their plasma samples are assessed for comparison. Participants will undergo plasma sampling for routine coagulation and Clinical Decision Support testing on fresh and frozen samples. Researchers will measure outcomes including reproducibility, threshold settings, sensitivity, specificity, likelihood ratios, exclusion percentages, and negative predictive values of the Clinical Decision Support tool over periods of 37 to 48 months. The study aims to verify if fresh plasma testing can match frozen plasma performance, potentially impacting diagnostic algorithms for VTE.

Age: 18Years +All Genders
4 locations
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Actively Recruiting

This research aims to describe how patients aged 18 years or older with moderate to severe atopic dermatitis AD are managed with systemic therapy. It focuses on patients eligible for or currently receiving systemic treatments, following their care under real-world conditions. The study involves French dermatologists experienced in AD management, whether practicing in hospitals or private offices. Treatment decisions are made independently by the physicians and not influenced by the study enrollment. Participants will receive systemic treatments for AD prescribed by their doctors as part of routine care, with no investigational drugs involved. Information will be collected during regular visits according to usual clinical practice. The study will follow patients for one year, tracking their treatments and management without altering standard care. During the year, patients will be assessed at baseline, 6 months, and 12 months. Researchers will collect data on previous and current treatments, treatment adherence, changes in disease severity, itch, sleep disturbance, skin pain, quality of life, psychological health, work absences, and hospitalizations related to AD. This comprehensive follow-up aims to better understand how systemic therapies are used and their impact on patients in everyday clinical settings.

Age: 18Years +All Genders
62 locations
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Actively Recruiting

This research aims to confirm and support the safety and clinical performance of eight different iVascular devices used for endovascular interventions in patients with artery disease affecting the renal, iliac, or femoral arteries. The study involves a real-world population of 209 patients who have undergone these procedures as part of standard care. The goal is to evaluate these devices in typical clinical settings to better understand their use and outcomes. Participants will undergo the same endovascular intervention procedure using one or more of the investigational devices from iVascular. These devices include the Oceanus 18 and Oceanus 35 Balloon Dilatation Catheters, Luminor 18 and Luminor 35 Drug Coated Balloons, Restorer Peripheral Stent System, iVolution Pro Peripheral Self-Expanding Stent System, iCover Covered Peripheral Stent System, and Sergeant Peripheral Support Catheter. The procedure and device use follow the instructions for use specific to each device. During the study, researchers will monitor patients from the time of procedure up to two years afterward. They will assess freedom from serious adverse events and device-related events as primary safety measures, along with the technical success of the procedure. Physicians will also provide ratings of the devices during the procedure. Follow-up includes an exploratory endpoint assessment up to two years post-procedure to understand longer-term outcomes and device performance.

Age: 18Years +All Genders
6 locations
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Actively Recruiting

Researchers are conducting a long-term observational study to understand how dupilumab is used and its effects in patients with Chronic Obstructive Pulmonary Disease COPD who are treated as part of routine care. This study will follow about 350 to 500 participants in multiple sites across France over 36 months, collecting detailed information on patient characteristics, safety, and patient-reported outcomes. The goal is to describe various aspects of COPD and treatment history to better characterize this patient group. Participants in this study are those newly starting dupilumab treatment for COPD, as prescribed by their doctors in line with approved guidelines. The study does not involve any additional treatment but observes the use of dupilumab over time. No placebo or comparator group is included. Data will be collected retrospectively and prospectively, covering medical history before dupilumab initiation and ongoing treatment effects during the 36-month follow-up. Throughout the study, researchers will gather detailed data on demographics, disease characteristics, lung function, exacerbations, comorbidities, and patient-reported assessments such as quality of life and symptom scores. Safety outcomes, including adverse events and reasons for stopping treatment, will be monitored. The study duration for each participant is about 36 months, allowing long-term observation of treatment and disease progression in real-world conditions.

Age: 18Years +All Genders
22 locations

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