Walls

Researchers are evaluating the safety and effectiveness of the Variable Compression System VCS device for adults with moderate to severe Irritable Bowel Syndrome IBS, including constipation-predominant, diarrhea-predominant, or mixed types based on Rome Criteria. This pilot, interventional trial aims to understand how well this wearable device works in managing IBS symptoms and its potential side effects. The study involves wearing the VCS device, which provides compression to the lower abdomen, torso support, and emits Far Infrared Radiation FIR over the torso. Participants will wear the device for at least 6 hours daily. Follow-up visits are scheduled at 21 days, 8 weeks, and 6 months after starting to use the device to monitor progress and gather data. During the study, participants will be assessed for any treatment-related side effects, including intolerable and emergent adverse events within 21 days. Researchers will also track changes in IBS symptoms. The total participation includes monitoring over several months, with evaluations at multiple time points to understand both safety and symptom changes over time.

Researchers are evaluating the effect of adding intensity-modulated post-operative radiation therapy I-PORT to standard chemotherapy or immunotherapy in patients with non-small cell lung cancer NSCLC who still have lymph node cancer after surgery. This phase II trial aims to see if I-PORT improves disease-free survival and whether it increases serious heart or lung side effects compared to standard care alone. The study also looks at overall survival, cancer control, and patient-reported symptoms related to heart and lung health. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy or immunotherapy alone, continuing treatment if the cancer does not progress or side effects are manageable. The other group receives I-PORT once daily Monday through Friday for 5 to 6 weeks, starting 4 to 12 weeks after surgery, followed by the same standard chemotherapy or immunotherapy. Imaging scans and blood samples are collected during treatment in both groups. After completing treatment, participants are followed for five years with check-ups every three months for two years, then every six months for three years. During these visits, researchers assess disease recurrence, survival, side effects, and patient symptoms. The study uses various scans including CT, MRI, and FDG-PET, along with blood tests, to monitor participants health and treatment impact over time.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

Researchers are evaluating the addition of a live biotherapy called MO-03 to standard immunotherapy treatments in patients with advanced or metastatic clear cell renal cell carcinoma, a type of kidney cancer that has spread beyond its original site. This phase III trial compares the effects of standard immunotherapy alone versus standard immunotherapy combined with MO-03, which contains beneficial bacteria that may improve gut health and potentially enhance immunotherapy effectiveness. Participants are randomly assigned to one of two groups one group receives MO-03 orally twice daily along with standard immunotherapy regimens tailored by risk level, and the other group receives a placebo along with the same immunotherapy regimens. The immunotherapy regimens include various drugs such as ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, administered intravenously or orally over cycles lasting 42 days, for up to 3 years unless disease progression or unacceptable side effects occur. Throughout the study, participants undergo regular imaging scans like CT or MRI and blood tests to monitor their health and response to treatment. Those with suspected bone or brain metastases may have additional scans. After completing treatment, participants are followed every 6 months for 2 years, then annually for up to 5 years to assess progression-free survival, overall survival, treatment response, and safety. Biological samples are also collected for future research.

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase IIIII trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.

Researchers are studying the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating combinations of targeted drugs in people with advanced non-small cell lung cancer that has spread and shows specific changes in the EGFR and MET genes. This phase II Lung-MAP trial focuses on patients whose cancer has progressed after treatment with osimertinib and aims to compare the effectiveness of combining capmatinib, osimertinib, and ramucirumab. The study also investigates safety, response rates, and survival outcomes while collecting biological samples for further analysis. Participants are randomly assigned to one of two groups. One group receives capmatinib and osimertinib as oral medications plus ramucirumab given intravenously, while the other group receives only capmatinib and osimertinib orally. During the trial, patients undergo regular CT or MRI scans and blood sample collections to monitor their disease and treatment effects. The study includes detailed assessments of tumor responses and side effects over time. Throughout the trial, participants will have scans and blood tests at scheduled intervals to assess disease progression and treatment impact. Researchers will monitor progression-free survival as the main outcome, along with response duration and toxicity. Blood samples are also collected to study circulating tumor DNA. The study continues up to three years, with ongoing safety and efficacy evaluations. Participants must meet specific health criteria and provide informed consent before joining.

The trial investigates treatments for younger patients with intermediate risk acute myeloid leukemia AML. It compares three therapy combinations cytarabine with daunorubicin, cytarabine with daunorubicin plus venetoclax, and venetoclax with azacitidine. This phase II study aims to evaluate whether adding venetoclax improves the elimination of leukemia cells compared to standard treatment, focusing on measurable residual disease MRD after remission. Participants are randomly assigned to one of three arms. Arm I receives daunorubicin intravenously on days 2-4, cytarabine intravenously on days 2-8, and venetoclax orally daily on days 1-11, with possible reinduction based on bone marrow assessment. Arm II receives azacitidine intravenously or subcutaneously on days 1-7 or 1-5 and 8-9, plus venetoclax orally daily on days 1-28 for two cycles. Arm III receives daunorubicin intravenously on days 1-3 and cytarabine intravenously on days 1-7, with possible reinduction depending on bone marrow results. Treatment continues unless disease progresses or side effects become unacceptable. During the trial, participants undergo bone marrow aspiration, blood sample collection, and heart function tests like echocardiography or MUGA scans. After treatment, follow-up visits occur at 4 weeks, then every 3 months for one year, every 6 months for the second year, and yearly afterward. Researchers assess outcomes such as undetectable MRD rates, remission rates, survival, relapse, and treatment side effects over several years.

Researchers are evaluating the addition of a stem cell transplant with melphalan after chemotherapy with daratumumab, cyclophosphamide, bortezomib, and dexamethasone Dara-VCD compared to Dara-VCD chemotherapy alone for patients newly diagnosed with amyloid light chain AL amyloidosis. This phase III trial aims to assess outcomes such as major organ deterioration progression-free survival, overall survival, organ response rates, and quality of life. The study also investigates minimal residual disease negativity and treatment-related side effects. Participants initially receive induction therapy with Dara-VCD drugs over a series of 28-day cycles, including daratumumab and hyaluronidase-fihj subcutaneously, bortezomib subcutaneously, cyclophosphamide orally or intravenously, and dexamethasone orally or intravenously. After induction, those with a partial response or better are randomized to one of two consolidation arms either continued Dara-VCD chemotherapy or high-dose melphalan chemotherapy followed by autologous stem cell transplant. Following consolidation, patients receive maintenance daratumumab and hyaluronidase-fihj therapy every 28 days for up to 18 cycles, unless the disease progresses or unacceptable toxicity occurs. Throughout the study, participants undergo multiple assessments including CT, MRI, or PET-CT scans, fat pad biopsies, echocardiography, bone marrow aspiration and biopsies, and blood and urine sample collections at regular intervals. Patient-reported outcomes related to physical function, fatigue, and symptoms are collected using standardized questionnaires. After completing study treatment, patients are followed up every 3 to 6 months for up to 4 years to monitor progression and overall health.