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Found 16 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.
Actively Recruiting
Researchers are studying an experimental drug called linvoseltamab in adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. The study aims to compare the effects and safety of linvoseltamab combined with standard treatment against the standard treatment alone. This is a Phase 3 randomized, open-label trial sponsored by the European Myeloma Network B.V. Participants will receive either the combination of daratumumab, lenalidomide, dexamethasone, and linvoseltamab or continued treatment with daratumumab, lenalidomide, and dexamethasone alone. Treatments will be given according to the study protocol, and participants will be randomly assigned to one of these two groups. The study will continue for up to 11 years to assess long-term effects. During the study, participants will undergo various assessments including measurements of minimal residual disease MRD, progression-free survival, overall survival, and response rates. Quality of life will also be evaluated using standardized questionnaires. Safety will be closely monitored by tracking adverse events and laboratory tests. Participants will be followed up for up to 11 years, with regular visits to assess disease status and treatment impact.
Actively Recruiting
Researchers are studying patients with hormone receptor-positive, HER2-negative early breast cancer HRHER2- EBC who are at high risk of their cancer returning. This observational study includes both past and future phases to assess the clinical and pathological features, treatment choices, and outcomes of patients treated with CDK46 inhibitors ribociclib or abemaciclib combined with endocrine therapy in the adjuvant setting. The study also focuses on patients whose cancer returned during or within 12 months after finishing this adjuvant treatment. Participants are those who have started or are starting adjuvant treatment with ribociclib or abemaciclib along with endocrine therapy since January 1, 2021. This study does not involve assigning treatments but observes patients receiving these therapies in real-world settings. It gathers data on treatment patterns, recurrence, and clinical outcomes without altering patient care. During the study, researchers will collect and analyze data on patient health, tumor characteristics, and treatment responses. They will track invasive disease-free survival over 3 years as the main outcome, along with distant relapse-free survival, progression-free survival, and overall survival up to 5 years. Participants will provide consent for their data to be used, and their health status will be monitored through routine medical records and follow-ups. The study is expected to continue until August 2030.
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.
Actively Recruiting
This research investigates patients who have experienced aneurysmal subarachnoid hemorrhage aSAH, a type of stroke caused by bleeding from a ruptured brain aneurysm. The study focuses on a complication called delayed ischemic neurological deficit DIND, which can lead to delayed cerebral ischemia and poor neurological outcomes despite early treatment. Researchers aim to understand how often DIND occurs, how it is diagnosed, and the treatments used across different centers, as well as the impact on patients recovery both short- and long-term. Participants include those diagnosed with aSAH, confirmed by imaging tests, who are admitted to intensive care. The study collects data on neurological symptoms and imaging to identify DIND and monitors instrumental methods like continuous EEG and ultrasound for diagnosis, especially in patients unable to be examined clinically. Researchers also observe various treatment approaches such as blood pressure management, local drug infusions, and mechanical interventions like angioplasty to compare their use and outcomes. During participation, patients undergo neurological examinations and imaging tests including CT and MRI to assess brain function and injury. Instrumental monitoring of intracranial pressure and cerebral blood flow is recorded to support diagnosis and management. The study follows patients for 12 months to measure the incidence of DIND and evaluate neurological and functional outcomes over time. Data on treatment intensity and monitoring usefulness are also collected to improve understanding of managing this condition.
Actively Recruiting
Researchers are investigating how imaging techniques like ultrasound and magnetic resonance imaging, along with clinical, laboratory, and patient-reported outcome measures, change over the first six months in people with active Psoriatic Arthritis or Rheumatoid Arthritis starting treatment with the drug Upadacitinib. This study focuses on understanding these changes in patients beginning this therapy to better monitor disease activity and treatment response. This observational study enrolls patients with active Psoriatic Arthritis or Rheumatoid Arthritis who are prescribed Upadacitinib by their doctors. Participants will be evaluated at treatment start and followed up at 2 weeks, 1 month, 3 months, and 6 months. Clinical assessments, laboratory tests, and ultrasound of affected joints will be done at each visit except the 2-week check. For those with axial disease, MRI scans will be performed at baseline and after 6 months if clinically indicated. During the study, data from clinical exams, lab tests, imaging, and patient questionnaires will be collected to measure disease activity and treatment effects. The main outcome is the change in ultrasound synovitis scores from baseline to 24 weeks. Other measures include various ultrasound scores, MRI indices, joint counts, inflammation markers, patient and physician assessments, and adverse events. This comprehensive follow-up aims to provide detailed information about disease progression and response to Upadacitinib over six months.
Actively Recruiting
Researchers are evaluating elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive ER and human epidermal growth factor receptor 2-negative HER2- breast cancer who have a relapse detected by circulating tumor DNA ctDNA. This international, multi-center, randomized, open-label phase III trial focuses on patients without distant metastasis who show ctDNA positivity during screening. The study aims to assess whether elacestrant can improve outcomes over the current standard endocrine treatments. The study consists of two phases. First, during the ctDNA screening phase, patients on standard adjuvant endocrine therapy will have plasma samples collected every six months for about 5.7 years to detect ctDNA. Patients who test positive will undergo imaging to confirm no distant metastasis and then be randomized 11 to either continue their current endocrine therapy or receive elacestrant 400 mg orally once daily. Treatment duration depends on prior endocrine therapy length, lasting between 2 to 6 years. Intensive follow-up with ctDNA testing and imaging occurs for up to 3 years after randomization. Participants will be monitored closely with blood tests for ctDNA at weeks 4, 16, and every 16 weeks thereafter, along with yearly mammograms, bone scans, and CT scans every 16 weeks to detect metastases or recurrences. Safety, quality of life, and overall survival are assessed throughout, with follow-up continuing until three years after the last patient enrolls. The primary outcome measured is distant metastasis-free survival at 6.25 years after the first randomization.
Actively Recruiting
Researchers are evaluating how a healthy lifestyle implemented through a Survivorship Care Plan LS-SCP may affect the quality of life for long-term lymphoma survivors who have been in remission for at least three years and up to ten years. The study focuses on patients with classical Hodgkin lymphoma, Diffuse Large B-cell lymphoma DLBCL, or Primary mediastinal large B-cell lymphoma PMBCL who have completed first-line therapy and are aged between 18 and 50 years. This randomized, open-label, multicenter trial aims to understand the impact of lifestyle changes on survivors well-being over time. Participants are randomly assigned to one of two groups the experimental arm receives a Survivorship Care Plan including a nutritional plan and physical activity guidance for six months, with bi-monthly automated calls to support adherence. The control arm receives no specific intervention and follows standard clinical care with self-administered questionnaires at 6 and 12 months. Both groups complete assessments using validated questionnaires at baseline, 6 months, and 12 months to evaluate various health and quality of life measures. During the study, participants undergo clinical assessments and complete questionnaires such as the EORTC QLQ-C30, SF12, MEDI-LITE, Chronic Fatigue Syndrome Self-assessment, Fatigue Assessment Scale, and Hospital Anxiety and Depression Scale. Researchers will monitor outcomes including global quality of life, psychosocial well-being, fatigue frequency, cognitive function, metabolic health, cardiovascular events, adherence to healthy behaviors, and overall survival for up to 30 months from study start. The study includes safety follow-up and compliance tracking to understand how lifestyle interventions might support long-term health in lymphoma survivors.
Actively Recruiting
Researchers are evaluating a medicine called elranatamab in people with multiple myeloma MM, a type of cancer. This study compares elranatamab to other commonly used combination therapies for MM that has returned or not responded to previous treatments. Participants must be 18 years or older and have received prior treatments, including an anti-CD38 antibody and lenalidomide. The study is a phase 3, randomized trial sponsored by Pfizer. Participants will be randomly assigned to receive either elranatamab alone or one of several combination therapies chosen by the study doctor. Elranatamab is given as a shot under the skin at the study clinic about once a week, with possible adjustments later. The combination therapies include two to three medicines taken by mouth or given by injection or infusion at the clinic. Treatment continues until the multiple myeloma stops responding. During the study, participants attend regular visits to monitor their response and side effects. Follow-up continues after treatment ends through telephone contacts or visits. Researchers will measure outcomes such as progression-free survival, overall survival, response rates, duration of response, and quality of life over approximately five years. Safety monitoring includes tracking adverse events and laboratory results throughout and after treatment.
Actively Recruiting
Researchers are conducting a multicenter, observational study in Italy to collect detailed information on patients with bone metastases. The study aims to establish a national database to better understand clinical and biological factors related to primary tumors and their bone metastases. This research will also evaluate the impact of treatments and care pathways on skeletal events over a period of up to 15 years. Patients with bone metastases from solid tumors will be enrolled in this study and registered in a specialized online database. Each participant will be followed from enrollment until death or until they stop follow-up for other reasons. The study does not involve any experimental treatments but collects comprehensive data on patients conditions and care. Participants will provide informed consent and their medical data will be regularly recorded and analyzed. The study monitors clinical outcomes, skeletal-related events, and the efficiency of treatment pathways. Data collection will continue for up to 15 years, providing long-term insights into bone metastases and patient management.
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