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Found 11 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating two digital mindfulness meditation programs to support mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III trial focuses on women diagnosed with breast cancer at age 50 or younger who have completed their main cancer treatments at least six months ago. The study aims to compare a live, instructor-led online program to a self-paced app-based program and also to explore factors that might influence how well these interventions work, including psychological distress levels and social factors like race and education. Participants will be assigned to one of three groups: a live online Mindful Awareness Practices (MAPs) program delivered over Zoom, a self-paced MAPs digital app, or a meditation-only control group. The live online program includes guided meditations, exercises to manage pain and emotions, and cultivating kindness, with daily home practice increasing from 5 to 20 minutes. The app program unlocks lessons sequentially as participants progress. Meditation use will be tracked across all groups to measure engagement. During the study, participants will report depressive symptoms two weeks after completing the intervention. Researchers will also collect information on emotion regulation strategies and social determinants of health, and monitor how much participants practice mindfulness to understand the programs' effects. The total intervention lasts six weeks, and participants must be able to use a digital device and communicate in English or Spanish. Safety and participation are closely monitored throughout the study.

Age: 18Years - 50YearsAll GendersPhase 3
299 locations
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Actively Recruiting

Lymphedema is a progressive and incurable condition causing swelling in the upper or lower limbs, affecting millions of people and leading to decreased quality of life and frequent infections. Currently, there are no approved drug treatments, and management relies mainly on compression therapy. This research explores the use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), commonly used to treat obesity and diabetes, as a potential new treatment for lymphedema, aiming to improve patients' quality of life and clinical outcomes. The study is a prospective, single-arm trial lasting 24 months, involving 110 adults with stage II lymphedema in one limb. Participants will receive GLP-1 RA treatment prescribed by their primary care provider for six months. Follow-up visits will occur at baseline, 3 months, and 6 months after starting treatment. Researchers will monitor changes in limb volume, bioimpedance, body mass index, compression use, and incidence of cellulitis. Participants will complete quality-of-life questionnaires using the Lymphedema Life Impact Scale at multiple time points. Other assessments include limb volume measurements and bioimpedance analysis. Data will be analyzed statistically to evaluate improvements. Safety monitoring and reporting of adverse events will be conducted throughout the study. The total study duration for each participant is six months of treatment with follow-up visits, within the overall 24-month study timeline.

Age: 18Years +All GendersEarly Phase 1
2 locations
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Actively Recruiting

Researchers are conducting a pilot trial called the LEAD Pilot Study to address lung cancer screening disparities by targeting eligible patients in the Emergency Department using an Electronic Health Record-embedded Social Determinants of Health screening tool. The study aims to evaluate the reach, or the number and representativeness of individuals targeted for lung screening knowledge, awareness, and uptake, and to assess the preliminary effectiveness of a tailored lung screening intervention compared to enhanced usual care. The trial uses quantitative methods including a randomized controlled trial and EHR data analysis to explore factors influencing lung screening uptake such as health literacy, mistrust, stigma, fatalism, and knowledge about lung screening.

Age: 50Years - 80YearsAll GendersPhase Not Applicable
10 locations
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Actively Recruiting

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Age: 18Years +All GendersPhase 2Phase 3
1201 locations
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Actively Recruiting

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Age: 18Years +All Genders
2284 locations
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Actively Recruiting

Researchers are exploring patient experiences with phrenic nerve reconstructive surgery as a treatment for diaphragmatic paralysis. This study uses a grounded theory approach to understand how this surgery affects patients, including their reported outcomes and the biopsychosocial aspects of surgical evaluation. Participants are individuals diagnosed with diaphragmatic paralysis who are scheduled to have phrenic nerve reconstructive surgery. The study focuses on gathering detailed patient feedback through interviews conducted before and after the surgery. Participants will be interviewed one week before and again 12 months after their surgery to share their experiences and outcomes. These semi-structured interviews help researchers learn about the surgery's impact on symptoms like chest pain and shortness of breath, as well as overall well-being.

Age: 18Years - 70YearsAll Genders
2 locations
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Actively Recruiting

Researchers are evaluating the use of Tamsulosin to reduce the high rate of postoperative urinary retention (POUR) in men aged 55 and older undergoing thoracic oncological surgery for suspected or confirmed cancer. This early phase 1 feasibility study aims to see if Tamsulosin can help patients resume normal urinary function after surgery and lower complications such as urinary tract infections and extended hospital stays. The condition affects mainly older men with enlarged prostates even after adjusting for other risk factors. Participants will take Tamsulosin 0.4 mg once daily after a meal for seven days before their scheduled surgery. After surgery, bladder ultrasounds will be performed about six hours post-operation to measure urine volume and check for retention. Depending on the ultrasound results and the patient's ability to urinate naturally, the study will monitor and manage bladder function using intermittent catheterization if necessary, with further intervention considered if large urine volumes remain for more than 24 hours. During the study, researchers will track spontaneous urination within 6 to 8 hours after surgery, timing and volume of urine, residual urine measured within 24 hours, and any need for interventions due to inability to urinate. Standard bladder management will be provided as needed, with measurements taken using BladderScanner ultrasound. The study focuses on safety and efficacy of preventing POUR and requires monitoring for up to 24 hours post-surgery to assess urinary function recovery.

Age: 55Years +MALEEarly Phase 1
4 locations
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Actively Recruiting

Researchers are collecting data in the RSSearch4 Registry to better understand how Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) are used to treat life-threatening tumors and other conditions. This international, multi-year registry tracks patient characteristics, treatment practices, and outcomes to help identify the most effective uses of these therapies over time. The study includes patients with various diagnoses such as neoplasms, arteriovenous malformations of the central nervous system, and trigeminal neuralgia. Participants receive SRS or SBRT treatments tailored to their specific conditions, with details of each treatment plan and outcomes recorded in the registry. The registry supports the inclusion of both prospective and some retrospective patient data to capture short- and long-term outcomes. The data collection enables participants to analyze treatment effectiveness, share findings, and collaborate with other centers. During the study, patient data on treatment and outcomes are collected and monitored, including specific measures relevant to each condition. The registry is managed by an independent vendor ensuring privacy and security compliance. Overall survival is tracked for up to five years to evaluate treatment impact. Patients agree to participate by signing an informed consent document or verbally consenting, and no specific exclusion criteria apply beyond unwillingness to participate.

All Genders
13 locations
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Actively Recruiting

Researchers are evaluating a phase III trial comparing shorter chemo-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer (TNBC). This study focuses on whether the anthracycline-free treatment combined with pembrolizumab is at least as effective as the standard anthracycline-containing regimen in preventing breast cancer events. The trial also examines various secondary outcomes including pathological response, survival rates, safety, tolerability, patient-reported quality of life measures, and translational objectives related to tumor immune markers. Participants are randomly assigned to one of two treatment groups. The first group receives paclitaxel, carboplatin, and pembrolizumab intravenously followed by doxorubicin, cyclophosphamide, and pembrolizumab before surgery. The second group receives docetaxel, carboplatin, and pembrolizumab intravenously before surgery. After surgery, patients in both groups may continue pembrolizumab treatment. Blood samples may be collected throughout the trial for additional analyses. During the study, participants undergo multiple assessments including imaging, blood tests, and physical exams before starting treatment. Patient-reported outcomes such as fatigue and physical function are collected through questionnaires. Follow-up visits occur every six months for two years, then annually up to five years to monitor breast cancer event-free survival and overall health. Safety and quality of life are continuously evaluated, and banking of physical specimens is performed for future research.

Age: 18Years +All GendersPhase 3
963 locations
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Actively Recruiting

Researchers are studying the use of targeted genomic analysis of blood and tissue samples from patients with cancer, focusing especially on rare cancers with poor prognosis or those lacking effective treatments. This research aims to identify specific genetic changes that contribute to cancer development and to improve diagnosis and treatment options by analyzing the entire genetic makeup of cancer cells. The study collects detailed genomic data to support future research and clinical care. Participants provide blood and tumor tissue samples, which undergo next-generation sequencing to detect genetic mutations. These mutations are then reviewed to find those with available targeted therapies, and this information is shared with treating doctors to guide patient care or referrals to other studies. Previously collected tissue samples may also be analyzed, and blood samples are collected to examine circulating tumor DNA and cells. After the initial sample collection and analysis, patients are followed up every three months for two years, then every six months for up to fifteen years. During this time, researchers monitor the frequency of specific mutations and combinations in related genes, as well as the rate of actionable mutations in rare or poor prognosis cancers. The study also collects clinical outcomes, tumor genome data, and tumor tissue for further research and model development.

Age: 1Year +All Genders
11 locations

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