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Found 21 Actively Recruiting clinical trials
Actively Recruiting
The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time. The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of telisotuzumab vedotin compared to docetaxel in adults with previously treated non-squamous non-small cell lung cancer (NSCLC) that overexpresses c-Met. This phase 3 study focuses on participants with advanced or metastatic NSCLC who have specific genetic markers and have progressed after prior therapies. The study aims to assess changes in disease activity and adverse events over time. Participants will be randomly assigned to receive either intravenous telisotuzumab vedotin every two weeks or intravenous docetaxel every three weeks. Treatment continues until predefined discontinuation criteria are met. Those who benefit from the study treatment may have the option to continue receiving it through an extension or rollover study. Approximately 698 adults will be enrolled worldwide at about 330 sites. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure progression-free survival and overall survival for up to approximately 39 months. The study includes careful safety monitoring and evaluates the impact of treatment on disease progression and patient well-being.
Actively Recruiting
Researchers are evaluating the safety, effectiveness, and tolerability of upadacitinib in adolescents and adults with severe alopecia areata (AA), a condition where the immune system attacks hair follicles causing hair loss on the head, face, or other body parts. This phase 3 study involves about 1500 participants worldwide and compares upadacitinib to a placebo to assess treatment impact on severe AA. Participants are randomly assigned to one of three groups receiving either upadacitinib or placebo oral tablets once daily for up to 160 weeks. There is a chance for re-randomization at weeks 24 and 52 based on Severity of Alopecia Tool (SALT) scores. Those completing initial studies may join an extension study to receive upadacitinib for up to an additional 108 weeks. Follow-up occurs for 30 days after the last dose. Throughout the study, participants attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers measure the percentage of participants achieving a SALT score of 20 or less at week 24 and track adverse events up to 164 weeks. The study may involve a higher treatment burden compared to usual care due to frequent visits and evaluations.
Actively Recruiting
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.
Actively Recruiting
Researchers are evaluating the role of Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) with Mitomycin-C in patients with colon cancer that has spread to the peritoneum. The study focuses on patients undergoing complete surgical removal of these metastases combined with systemic chemotherapy. This Phase IV multicenter trial aims to determine if adding HIPEC with Mitomycin-C improves the time patients remain free from cancer recurrence in the peritoneal cavity, addressing limitations seen in previous studies using a different drug and treatment approach. Participants will be divided into two groups: one receiving complete cytoreductive surgery plus HIPEC with Mitomycin-C for 90 minutes, and the other undergoing surgery alone without HIPEC. The HIPEC procedure uses a dose of 35 mg/m2 Mitomycin-C delivered in a heated solution for 90 minutes with specific dose fractionation at set intervals. Only patients with limited volume peritoneal metastases, complete tumor removal, and colon (not rectal) cancer are included. Systemic chemotherapy is given before and/or after surgery as part of the treatment. During the study, patients will be closely monitored to confirm complete tumor removal and disease extent. Researchers will track peritoneal recurrence-free survival over three years as the primary outcome. Patients undergo assessments to ensure they meet health and surgical risk criteria before enrollment. Safety and disease progression are also regularly evaluated, with informed consent and ongoing follow-up care provided throughout the trial.
Actively Recruiting
Researchers are collecting detailed information about patients with venous thromboembolism (VTE), which includes blood clots in veins such as deep-vein thrombosis and pulmonary embolism. The project aims to improve doctors' understanding of VTE, especially in patients often excluded from clinical trials, like pregnant women, elderly individuals, cancer patients, and those with other complex health issues. The goal is to reduce deaths, clot recurrence, bleeding problems, and artery-related events by sharing this knowledge widely. The study involves gathering extensive data on each patient's health status, treatments, and outcomes during the first three months of therapy. This registry is available online to help doctors quickly find information on patients with similar medical profiles and make informed decisions about managing high-risk individuals. There are no specific interventions being tested; instead, the focus is on collecting real-world patient data. Participants provide informed consent and are followed for at least three years to monitor for new clot events and complications. Researchers track recurrences of VTE, bleeding episodes, and deaths, aiming to create tools that predict which patients are most at risk for problems. This ongoing data collection supports improving care and guiding treatment decisions for diverse patient groups over time.
Actively Recruiting
Healthy Volunteer
Researchers are investigating how combining physical exercise with transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, affects motor function in people with Parkinson's disease. Parkinson's disease causes motor symptoms that greatly impact quality of life, and while exercise has shown benefits for motor function, the underlying brain mechanisms and the potential added benefit of tDCS are not fully understood. This study aims to explore these effects and the neurophysiological changes behind any improvements. Participants will take part in one of three groups: reactive exercise combined with real anodal tDCS targeting the motor cortex on the side most affected by Parkinson's symptoms, reactive exercise combined with sham (placebo) tDCS, or reactive exercise alone. Each participant will complete 24 sessions of their assigned intervention. The study is controlled, blinded, and randomized to ensure reliable results. Throughout the 7-week treatment period, researchers will assess various aspects of motor function, such as walking speed, step length, cadence at both preferred and maximal speeds, performance on the Timed Up and Go test, and reaction times for stepping and arm reaching. These measurements will help determine any motor improvements. The study also includes electrophysiological assessments like electroencephalography and transcranial magnetic stimulation to understand the brain activity changes related to the interventions.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of obefazimod compared to a placebo in adults with moderately to severely active Crohn's Disease who have not responded well or are intolerant to conventional or advanced treatments. The study is a Phase 2b trial and includes three treatment phases: a 12-week Induction Phase, a 40-week Maintenance Phase, and a 48-week Extension Phase. The main goals are to assess how well obefazimod controls disease activity and its safety over these periods. Participants will receive either obefazimod or a matching placebo once daily, preferably in the morning with food. The trial includes an initial 12-week treatment to induce response, followed by a 40-week maintenance period to sustain results. Those who complete these phases may enter a 48-week Extension Phase to further evaluate the long-term safety and tolerability of obefazimod compared to placebo. During the study, participants will undergo regular assessments including clinical evaluations of disease activity using the Crohn's Disease Activity Index and endoscopic scoring at various time points up to week 52. Safety is monitored throughout, especially during the Extension Phase with checks for adverse events, blood tests, and other laboratory evaluations at scheduled visits. Overall, participation may last over a year, with careful monitoring of treatment effects and safety.
Actively Recruiting
Researchers are evaluating a large group of patients with advanced solid tumors who are starting their first line of cancer treatment with palliative intent. The study aims to analyze various genetic, phenotypic, environmental, social, and lifestyle factors and how these may relate to tumor response or tolerance to treatment. The goal is to identify key variables that could help improve patient selection and treatment decisions in oncology. Participants will be monitored using a wearable device, the Vivosmart Garmin bracelet, which continuously collects health data. This high-definition medicine approach seeks to establish a detailed personal baseline for each patient. By following a robust and sufficiently large cohort over time, researchers hope to understand how different health determinants influence treatment outcomes and tolerance. Throughout the study, patients will be followed prospectively for up to 36 months or until death or withdrawal. Researchers will collect a solid set of clinical, analytical, and epidemiological variables during this period. Participants will complete quality of life, nutrition, and mental health questionnaires, and their adherence to wearing the device and using related technology will be monitored. The study focuses on gathering comprehensive data to support personalized treatment strategies in advanced cancer care.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of LY4268989 when given together with mirikizumab compared to mirikizumab alone in adults with moderately to severely active ulcerative colitis (UC). This Phase 2 study focuses on adults aged 18 to 80 years who have had UC diagnosed for at least 3 months and have active symptoms confirmed by specific clinical scores and endoscopic evidence. The study aims to assess clinical remission using the Modified Mayo Score at 12 weeks. Participants will receive either LY4268989 by mouth combined with mirikizumab administered first intravenously and then by subcutaneous injection, or mirikizumab alone with a placebo pill. The entire study treatment period will last about 104 weeks, with up to 21 visits planned for monitoring. Treatment schedules and dosing are designed to compare the combination therapy to mirikizumab alone. During the study, participants will undergo regular assessments including clinical evaluations, endoscopy, and monitoring of symptoms and safety. Researchers will track the percentage of participants achieving clinical remission by week 12 using the Modified Mayo Score. Participants will be followed closely throughout the study duration, which totals approximately 118 weeks from start to finish, including treatment and follow-up visits.
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