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Researchers are evaluating AP301, a novel iron-based phosphate binder, in patients with chronic kidney disease who are receiving maintenance dialysis and have elevated blood phosphate levels. This phase 3, randomized, double-blind study aims to determine whether AP301 lowers blood phosphate and how it affects serum calcium, calcium times phosphate, and intact parathyroid hormone levels. The trial also assesses any discomfort or medical problems during treatment and its impact on quality of life in Chinese patients. Participants will first stop all phosphate-lowering medications. They will then take either AP301 or a low-dose comparator considered ineffective three times daily for 8 weeks. Following this, all participants receive AP301 three times daily for 24 weeks, with dose adjustments based on blood phosphate levels and physician judgment. Finally, participants will take either AP301 or the comparator three times daily for 3 weeks. Additional treatments may be given if blood phosphate levels become too high or low. During the study, participants will undergo regular assessments including blood tests to monitor serum phosphate, calcium, and parathyroid hormone levels. Electrocardiogram tests will measure changes in QT intervals. Safety is monitored by tracking adverse events throughout the trial, which lasts up to 37 weeks. The primary outcome is the change in serum phosphate concentration from baseline to the end of week 8, with ongoing evaluations over the entire study period.

Researchers are evaluating the safety, tolerability, and effectiveness of AP306 at fixed doses in adults with hyperphosphatemia who are receiving maintenance hemodialysis. Hyperphosphatemia is a common complication in advanced chronic kidney disease and is linked to serious risks such as cardiovascular problems, fractures, and mortality, especially in dialysis patients. This research is a randomized, double-blind, placebo-controlled Phase 2b study to better understand how AP306 affects phosphate levels in this population. Participants will receive AP306 in different fixed doses administered orally either twice or three times daily for 8 weeks, or a placebo given three times daily. The study includes seven different cohorts, six receiving various doses of AP306 and one receiving placebo. The treatment period aims to assess how these doses impact serum phosphate levels and the drugs safety and tolerability. During the study, participants will have their serum phosphate levels monitored to measure the drugs impact over the 8-week treatment period. Researchers will also assess the proportion of participants achieving target phosphate levels and the time it takes to see a response. Safety monitoring will include laboratory tests and assessments of adverse effects. The study expects full participation to span at least 8 weeks of treatment, with ongoing evaluation of tolerability and efficacy.

Researchers are studying autologous bone marrow stem cell mobilization using the drug Plerixafor to treat women with Ashermans Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure. The goal is to evaluate if Plerixafor can restore endometrial function and improve pregnancy implantation rates compared to standard treatments. This early phase 1 study involves women aged 18 to 40 years with specific diagnoses related to these conditions. The study involves a single subcutaneous dose of 20 mg Plerixafor administered the evening before scheduled standard care surgery for participants. Those weighing over 83 kilograms receive a weight-based dose of 0.24 mg per kilogram. Participants are grouped by their condition refractory Ashermans Syndrome, atrophic endometrium with thin lining, or recurrent implantation failure despite multiple embryo transfers. They will be monitored for changes in endometrial thickness and pregnancy outcomes over time. Participants will be asked to avoid NSAIDs two weeks before and 30 days after treatment and to abstain from intercourse for three months following administration. Assessments will include menstrual bleeding patterns, endometrial blood flow, and histology before treatment and at 3 and 6 months after. Researchers will track implantation rates and pregnancy outcomes every three to six months up to 24 months, with ongoing monitoring to evaluate the treatments impact and safety.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial focuses on patients with Stage IIB, IIC, or Stage III colon adenocarcinoma who have undergone tumor removal. The study aims to use ctDNA status to better predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy. Participants will be assigned to different treatment groups based on their ctDNA status after surgery. Patients without detectable ctDNA will undergo serial ctDNA monitoring without immediate treatment or receive standard chemotherapy regimens such as mFOLFOX6 or CAPOX for varying durations. Patients with detectable ctDNA will receive either standard chemotherapy or intensified regimens like mFOLFIRINOX. Treatments involve intravenous and oral chemotherapy drugs given over several cycles spanning weeks to months. Throughout the study, participants will have ctDNA testing using the Signatera test and be monitored for disease-free survival, overall survival, and recurrence up to five years after randomization. Safety and treatment adherence will also be tracked. Regular imaging and laboratory tests will assess disease status and organ function. The study may include re-randomization for patients who develop positive ctDNA during monitoring. Total involvement may last several years with follow-up for long-term outcomes.

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.

Researchers are evaluating two different monitoring approaches for pancreatic cysts and associated biomarkers to improve risk detection of progression to pancreatic cancer. This observational study aims to compare more frequent versus less frequent monitoring schedules and identify biomarkers from blood tests and imaging that may better predict the development of concerning features or high-risk signs. The study also assesses patient quality of life, financial distress, anxiety, and healthcare costs related to these surveillance programs. Participants undergo magnetic resonance imaging MRI, computed tomography CT, or endoscopic ultrasound EUS scans, as well as blood sample collections throughout the trial. The study originally randomized patients into two surveillance arms a low-intensity group with less frequent imaging and a high-intensity group with more frequent imaging based on cyst size. Patients may also undergo biopsies, fine needle aspiration, and surgery as clinically needed. The study is closed to new accrual but continues follow-up. Participants are followed every 6 to 12 months for up to 5 years after enrollment. Researchers collect imaging results, blood samples, and clinical data to track the development of worrisome cyst features or high-risk stigmata. They also evaluate patient-reported outcomes including quality of life, anxiety, and financial distress. Safety and treatment pathways are documented, and the primary outcome focuses on the time to detecting concerning cyst features on imaging over the 5-year period.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

This trial investigates how pausing combined hormonal contraceptives CHC affects planned egg freezing in women aged 18 to 40. Researchers are studying whether a 2-month break from CHC before starting ovarian stimulation leads to more eggs retrieved compared to starting immediately after stopping CHC. The study aims to understand if hormonal contraceptive use suppresses ovarian reserve markers and affects egg yield during fertility preservation. Participants will be randomly assigned to one of two groups one will take a 2-month break from CHC before egg freezing, and the other will start ovarian stimulation right after stopping CHC. Both groups will undergo planned oocyte cryopreservation procedures. This is a multi-center, randomized, quadruple-blind trial comparing these two approaches to optimize fertility preservation protocols. During the study, participants will have ovarian reserve markers like Anti-Mllerian hormone AMH measured before and after the drug holiday. The main outcomes measured are the number of eggs retrieved and the maturation rate of these eggs during retrieval. The study also monitors changes in AMH levels over 2 months. Participants will be assessed through blood tests and egg retrieval procedures, with safety and procedure tolerance followed throughout the trial.

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma, a condition where abnormal plasma cells grow in the bone marrow but without symptoms. This phase III trial evaluates how well lenalidomide and dexamethasone work together, with or without the addition of daratumumab, an immunotherapy drug. The study aims to compare overall survival, progression-free survival, response rates, and quality of life between these two treatment approaches. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on a set schedule alongside oral lenalidomide daily and dexamethasone on specific days within repeated 28-day cycles, up to 24 cycles. The other group receives lenalidomide and dexamethasone on a similar schedule without daratumumab. Treatment continues until disease progression or unacceptable side effects occur. After treatment, patients are followed up for up to 15 years to monitor long-term outcomes. Throughout the study, participants undergo evaluations including blood and urine tests, bone marrow biopsies, and imaging scans such as FDG-PETCT. Researchers assess treatment response, minimal residual disease status, safety, and quality of life using questionnaires. They also monitor treatment adherence and side effects, including infusion reactions. The main outcomes measured are overall survival and changes in quality of life. Safety and various laboratory and imaging markers are regularly reviewed to understand treatment effects and disease progression.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.