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This research investigates the effects of AP301, a new iron-based phosphate binder, in patients with chronic kidney disease who are receiving maintenance dialysis and have high blood phosphate levels. The study aims to find out if AP301 can lower blood phosphate and how it influences serum calcium, calcium times phosphate levels, and parathyroid hormone levels. Researchers also want to understand what side effects or discomfort patients might experience and whether AP301 improves quality of life in Chinese patients. The trial is a Phase 3, randomized, double-blind, multi-regional study comparing AP301 with a low-dose version of the same drug that acts as a placebo-like comparator. Participants will first stop all phosphate-lowering drugs. Then, they will take either AP301 or the low-dose comparator three times daily with meals for 8 weeks. After that, all participants will take AP301 three times daily for 24 weeks. Finally, they will take either AP301 or the comparator for 3 weeks. During the first 32 weeks, the dose of AP301 may be adjusted up or down based on blood phosphate levels and the study doctor's judgment. Additional treatment may be given if phosphate levels become too high or too low. Throughout the study, patients will be monitored for changes in serum phosphate levels, calcium levels, and parathyroid hormone levels. Researchers will also assess side effects and quality of life. The main outcome measured is the change in serum phosphate concentration from the start of the study to the end of week 8. Participation requires patients to be on dialysis for at least 3 months and to meet certain blood phosphate and calcium criteria, and the study will last at least 35 weeks with various assessments.

This study will assess the use of autologous bone marrow stem cells mobilization using 1,1'-\[1,4-phenylenebis-(methylene)\]-bis-1,4,8,11-tetraazacyclotetradecane (PLERIXAFOR) as an effective medical therapy for the treatment of Asherman's Syndrome (AS), Atrophic Endometrium (AE) and Recurrent Implantation Failure (RIF). Primary Objective: * To compare endometrial thickness and implantation rates in women with AS, AE, and RIF receiving PLERIXAFOR compared to historic controls that received existing standard of care therapy * To compare ongoing pregnancy and live birth rates in women with AS, AE, and RIF receiving PLERIXAFOR compared to historic controls that received existing standard of care therapy Secondary Objectives: (assessed in participants who have not achieved pregnancy as of the timepoint): \- Endometrial thickness prior to treatment with PLERIXAFOR compared to endometrial thickness 3 and 6 months after treatment. During this study, participants are asked to: * Refrain from use of non-steroidal anti-inflammatory drugs (NSAIDs) from 2 weeks prior to the start of the surgery/PLERIXAFOR administration, and for the 30 days following surgery/ PLERIXAFOR administration. * Abstain from intercourse for three months following surgery/PLERIXAFOR administration * Assessment of menstrual bleeding pattern before and 3 and 6 months following treatment with PLERIXAFOR * Assessment of endometrial blood flow before and 3 and 6 months following treatment with PLERIXAFOR * Assessment of endometrial histology three months following treatment with PLERIXAFOR The study intervention consists of administration of PLERIXAFOR the evening prior to scheduled standard of care surgery for women with AS, AE or RIF, for peripheral mobilization of stem cells. PLERIXAFOR is administered via the subcutaneous route, as a single dose of 20mg. The goal of this study is to determine if the administration of PLERIXAFOR for autologous, peripheral stem cell mobilization and administration will restore endometrial function in women with AS, AE, and RIF, and allow for pregnancy implantation.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are evaluating a phase II Lung-MAP treatment trial testing combinations of targeted drugs—capmatinib, osimertinib, and ramucirumab—to treat patients with advanced non-small cell lung cancer (NSCLC) that has spread and shows EGFR and MET gene changes. Capmatinib and osimertinib are kinase inhibitors that block abnormal proteins signaling cancer growth, while ramucirumab is an antibody that may stop new blood vessel growth needed by tumors. Targeting these gene changes may help shrink or control the cancer. Patients are randomized into two groups: one group receives capmatinib and osimertinib orally along with ramucirumab intravenously, while the other group receives capmatinib and osimertinib orally without ramucirumab. Throughout the study, participants undergo CT or MRI scans and provide blood samples. The treatments are given according to the assigned group to compare their effects and safety. During the trial, participants are closely monitored with imaging and blood tests to assess cancer progression and treatment side effects. The main measure is progression-free survival, tracking time until cancer worsens or death, over up to 3 years. Researchers also evaluate response rates, overall survival, toxicity, and collect tissue and blood samples to study tumor DNA. Participants' health status and laboratory values are regularly checked to ensure safety and effectiveness of the treatments.

Researchers are evaluating two different methods for monitoring pancreatic cysts to determine which approach leads to better outcomes for patients with these cysts. The study compares a lower intensity surveillance schedule with a higher intensity surveillance schedule in patients aged 50 to 75 years. The study also aims to assess differences in surgical complications, pancreatic cancer rates, mortality, costs, healthcare use, patient quality of life, anxiety, financial distress, adherence to surveillance, and the predictive value of biomarkers and radiomic markers for cancer or dysplasia. Participants are randomly assigned to one of two surveillance arms. In the low intensity arm, patients receive MRI or CT scans at the start and one year later, then repeat imaging every two years if no abnormalities are found. If positive features appear, imaging frequency increases. In the high intensity arm, surveillance frequency varies by cyst size, ranging from MRI or CT every six months to combined imaging and endoscopic ultrasound (EUS) every 3-6 months for larger cysts. EUS is used to further evaluate cysts based on size and findings. After imaging procedures, patients are followed for five years from enrollment. During the study, patients undergo procedures including MRI, CT, and EUS, along with quality-of-life and questionnaire assessments. Researchers will monitor clinical outcomes, imaging results, healthcare utilization, costs, patient-reported outcomes, and biomarker performance. Safety and adherence to surveillance schedules will be tracked. The study lasts five years after the initial registration to capture long-term outcomes related to pancreatic cyst monitoring.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

The trial investigates fertility preservation in women planning to freeze their eggs, focusing on whether pausing combined hormonal contraceptives (CHC) for two months before egg retrieval improves outcomes compared to starting immediately without a pause. It addresses the impact of long-term CHC use on ovarian reserve markers, which may suppress follicle development and reduce the number of eggs collected. The study responds to inconsistent previous findings by conducting a randomized, blinded clinical trial to better understand if a contraceptive pause could increase the number of eggs retrieved. Participants will be randomly assigned to one of two groups: one group will discontinue CHC for two months before planned egg freezing, and the other will begin the egg freezing process immediately without pausing CHC. The study will monitor ovarian response and egg retrieval outcomes. This approach aims to optimize ovarian stimulation timing and maximize egg yield while minimizing delays. During the study, women aged 18 to 40 who are not smokers and have a body mass index under 40 will participate. Researchers will assess the number of eggs retrieved and the rate at which eggs mature during the retrieval process. The study includes monitoring hormonal levels and ovarian reserve markers to evaluate the effect of the contraceptive pause. Participants will undergo standard procedures for ovarian stimulation and egg retrieval, and safety will be closely observed throughout the study period.

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma in this phase III trial. The study compares the effects of lenalidomide and dexamethasone given with or without daratumumab. These drugs work in different ways to stop tumor growth, and the combination with daratumumab, an immunotherapy, may better interfere with tumor cell growth and spread. The trial aims to assess overall survival, progression-free survival, treatment safety, and quality of life among participants. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on specific days across up to 24 cycles, combined with daily oral lenalidomide for 21 days and oral dexamethasone on days 1, 8, 15, and 22 for 12 cycles. The other group receives only lenalidomide and dexamethasone on the same schedule for up to 24 cycles. Treatment continues every 28 days until disease progression or unacceptable side effects occur. During the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans, and patient questionnaires to monitor treatment effects and quality of life. Researchers track overall survival for up to 15 years, evaluate minimal residual disease, and monitor medication adherence and adverse events. Follow-up visits occur every 3, 6, or 12 months after treatment ends to continue monitoring health outcomes.

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.

Researchers are evaluating the use of osimertinib alone versus a combination of osimertinib and bevacizumab for treating advanced non-small cell lung cancer (NSCLC) that has spread beyond the lungs and has specific mutations in the EGFR gene. This phase III trial focuses on whether adding bevacizumab, which blocks blood vessel growth to tumors, can better control cancer and improve survival compared to osimertinib alone, a drug that blocks EGFR involved in cancer cell growth. Patients are randomly assigned to receive either osimertinib by mouth once daily or osimertinib with bevacizumab given intravenously every 21 days. Treatment continues unless the cancer progresses or side effects become unacceptable. The study includes imaging tests like CT, MRI, echocardiography, and MUGA scans to monitor disease and heart function, along with blood and urine sample collection. Participants are followed for up to 10 years after treatment ends, with check-ups every 3 months to measure progression-free survival, overall survival, response rates, and side effects. Researchers also analyze blood samples to study how the cancer develops resistance to treatment. This thorough monitoring helps understand long-term effects and how well the treatments control the cancer.