Endometrial Hyperplasia

Researchers are collecting real-world data on the Cerene Cryotherapy Device, which was approved by the FDA in 2019 for treating heavy menstrual bleeding in premenopausal women who have completed childbearing. This observational study aims to compare outcomes from routine clinical use of the Cerene device with results from previous pivotal studies, helping to understand its effectiveness and safety in everyday practice. Participants in this registry will have received treatment with the Cerene device as part of their standard medical care. The study does not involve any additional active interventions beyond this treatment. Data collection includes patient and physician surveys covering demographics, quality of life, procedural details, and clinical outcomes following the Cerene treatment. Women will participate for about 13 months, starting from enrollment and continuing through a 12-month follow-up after treatment. During this time, surveys will be completed at multiple points to assess re-intervention rates, quality of life, site of service, physician feedback, and cost analysis. The study concludes after the last participant completes her one-year follow-up visit.

Researchers are evaluating DM002, an investigational bispecific antibody-drug conjugate targeting MUC1 and HER3, in adults with advanced solid tumors such as ovarian, prostatic, endometrial, colorectal, and pancreatic cancers. This study has two parts Part 1 focuses on finding the safest and most effective dose through dose escalation, while Part 2 expands the evaluation at the best dose found in Part 1 to further assess safety and cancer response. Participants receive DM002 through intravenous infusion on Day 1 every three weeks. Part 1 involves up to six or more dose levels tested sequentially to determine safety and optimal dosing. In Part 2, participants receive the recommended dose established from Part 1. Dose adjustments may occur based on safety and pharmacokinetic data. The treatment cycles last 21 days each. Participants will have at least 17 visits, including a screening phase lasting up to 28 days, treatment cycles every 21 days, an End of Treatment visit 21 days after the last dose, and a Follow-up visit 30 days later. Phone contacts will continue every three months to monitor well-being and any new anticancer therapies started. Researchers will monitor dose-limiting toxicities, maximum tolerated dose, drug levels in the body, and tumor response throughout the 12-month study period.

Researchers are evaluating LY4170156, an antibody-drug conjugate targeting folate receptor alpha-expressing tumor cells, in participants with selected advanced solid tumors. This phase 1a1b trial aims to assess the safety, tolerability, and preliminary effectiveness of LY4170156 given alone or in combination with other drugs such as bevacizumab, carboplatin, pembrolizumab, and itraconazole. The study includes dose escalation, dose optimization, and dose expansion parts and is expected to last up to approximately 4 years. Participants receive LY4170156 administered intravenously at escalating or optimized doses. Some groups receive the drug alone, while others receive it combined with bevacizumab, carboplatin, pembrolizumab, or itraconazole oral. The trial compares different doses during dose escalation and evaluates the recommended phase 2 dose. Treatment cycles are generally 21 days in length. During the study, participants undergo regular monitoring for safety and tumor response. Researchers assess outcomes such as the recommended phase 2 dose, overall response rate, duration and time to response, progression-free survival, and disease control rate. Pharmacokinetics of LY4170156 alone and in combination are also studied. Monitoring for serious adverse events related to the drug occurs throughout the study, which may last up to 4 years per participant.

This research aims to assess the safety and effectiveness of LY4175408 in adults with certain advanced or metastatic solid tumors, including non-small cell lung cancer, small cell lung cancer, endometrial cancer, and triple negative breast cancer. The study also investigates how LY4175408 is processed in the body, including its levels in the blood, breakdown, and elimination. Participants may be involved for up to four years. Participants receive LY4175408 through intravenous infusion in dose escalation and expansion phases. Some groups will receive LY4175408 alone, while others will receive it combined with pembrolizumab, and in some cases with carboplatin or cisplatin, also given intravenously. The study includes multiple cohorts with varying dosing schedules to evaluate safety, tolerability, and preliminary efficacy. During the trial, participants undergo regular assessments including monitoring for dose limiting toxicities within 21-day cycles and evaluations of response such as complete or partial tumor response over up to four years. Pharmacokinetic measurements track the drugs concentration in the blood during the first 84 days. Other measures include progression-free survival, disease control rate, duration and time to response. Safety and efficacy outcomes are closely followed throughout the participation period, which can last up to four years.

Researchers are studying LY4257496, a radioligand therapy, to evaluate its safety, tolerability, and effectiveness alone or combined with standard cancer treatments in adults with advanced cancers that test positive for Gastrin-releasing Peptide Receptor GRPR. These cancers include breast, colorectal, prostate, endometrial, esophageal, gastroesophageal junction, and stomach cancers. The study also assesses LY4257529 to identify tumors with high GRPR levels. This Phase 1 study aims to find the best dose and response to treatment. Participants will receive LY4257496 administered intravenously, either alone or along with standard anticancer therapies like Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, or Abemaciclib. The study has different groups receiving varying doses or combinations, including dose escalation and dose optimization phases. LY4257529 will be administered intravenously at select sites to help identify GRPR-positive tumors. Treatment cycles last 28 days, with follow-up extending to about 42 weeks. During the study, participants will undergo imaging tests such as CT or MRI to monitor tumor response and confirm measurable lesions. Researchers will track safety by monitoring dose-limiting toxicities and drug levels in the body. Participants will have regular clinic visits for treatment administration, laboratory tests, and evaluations. The main outcome is the maximum tolerated dose and the percentage of participants showing tumor shrinkage. Participation may last up to 36 weeks or until the tumor progresses.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of a novel oral drug called NKT3964 in adults with advanced or metastatic solid tumors. The study aims to find the recommended dose for further testing and to observe how the drug affects various types of advanced cancers, including ovarian, endometrial, gastric, lung, and breast cancers, particularly those with specific genetic markers like CCNE1 amplification. The study has two main phases Dose Escalation and Dose Expansion. In the Dose Escalation phase, participants receive increasing doses of NKT3964 to assess safety, side effects, and appropriate dosing. The Dose Expansion phase uses the recommended dose from the first phase to further evaluate the drugs anti-tumor activity in specific tumor types. Both phases involve oral administration of the study drug, with detailed criteria for patient eligibility based on cancer type, prior treatments, and genetic markers. Participants will undergo regular assessments including physical exams, laboratory tests, imaging scans, and tumor biopsies before and during treatment. Researchers will monitor drug levels in the blood, treatment side effects, and tumor responses using standard criteria over periods ranging from one month to two years. The study also tracks progression-free survival, overall survival, and other measures to understand the drugs impact and safety profile. Participation involves ongoing monitoring and follow-up visits throughout the study duration.

Researchers are evaluating the effects of Dostarlimab alone or combined with Bevacizumab compared to standard nonplatinum chemotherapy in women with recurrent gynecological clear cell carcinoma, including cancers of the ovary, endometrium, cervix, vagina, and vulva. This phase II, randomized, open-label study aims to understand which treatment approach may better control disease progression and improve outcomes in this patient population. Participants will be divided into three groups Group A receives Dostarlimab alone with an initial dosing of 500 mg every 3 weeks for 3 cycles, followed by 1000 mg every 6 weeks for up to 24 months. Group B receives the same Dostarlimab schedule plus Bevacizumab at 15 mgkg every 3 weeks until disease progression or unacceptable side effects. Group C receives general chemotherapy with one of the drugs Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, or Gemcitabine. All treatments are given intravenously. During the study, participants will be monitored for disease progression, with the primary measure being progression-free survival for up to about 48 months. Secondary outcomes include response rates, disease control, overall survival, and safety over up to 72 months. Tumor tissue samples will be collected for research, and participants will undergo regular evaluations including imaging and laboratory tests. The study follows patients for a long period to assess treatment effects and safety.

Researchers are investigating the effects of a high-fat mixed meal containing a whey protein-enriched milk fat globule membrane MFGM supplement on heart and brain health markers in middle-to-older-aged, postmenopausal women who are overweight and at moderate risk for cardiovascular disease. This randomized, single-blind, placebo-controlled crossover study aims to understand how this specific nutritional ingredient influences post-meal responses related to cardiovascular and cognitive health. Participants will attend two approximately 8-hour visits. During each visit, they will consume a high-fat meal containing about 75 grams of refined palm oil fat supplemented either with a whey protein-enriched MFGM powdered ingredient or a placebo whey protein-based powdered ingredient without MFGM. The meals are matched for energy and protein content and given in random order with a washout period of at least 21 days between visits. During each visit, researchers will take body measurements and periodically assess heart health through blood pressure and blood vessel stiffness tests. Blood samples will be collected at multiple time points before and after the meal, over a 6-hour period, to measure changes in blood fats, glucose, insulin, and inflammatory markers. Participants will also complete computer-based tests to assess mood and cognitive function. The study will monitor how the supplement affects these heart and brain health markers in the hours following a meal.

Researchers are evaluating the effects of relaxation and breathing training delivered by a physiotherapist compared to an artificial intelligence-assisted system in postmenopausal women with chronic musculoskeletal pain. The study focuses on women aged 45 to 65 who are experiencing pain related to the natural decline in estrogen levels after menopause, which affects muscle and bone health as well as quality of life. This randomized controlled trial aims to compare traditional and AI-based relaxation methods to support symptom management in this population. Participants will be randomly assigned to one of three groups physiotherapist-led face-to-face sessions, AI-assisted training through prerecorded audio exercises on a smartphone or tablet, or a control group receiving general information without structured training. The interventions last eight weeks with sessions three times per week, each about 30 minutes. The physiotherapist-led group receives supervised training, while the AI group follows exercises created and voiced by AI technology and logs their practice daily. The control group continues their usual routines during the study period. Participants undergo assessments at the start and end of the eight weeks to measure pain intensity, pressure pain threshold, menopause-specific quality of life, musculoskeletal symptoms, psychological state, sleep quality, dyspnea, and satisfaction with the program. The study monitors these outcomes to understand how each training method affects pain, physical function, sleep, and psychological well-being. The trials findings aim to inform accessible and cost-effective approaches to improve daily functioning in postmenopausal women.

Gastric adenomas with low-grade dysplasia LGD are precancerous stomach lesions with a lower risk of progressing to cancer compared to high-grade dysplasia. This trial aims to compare two common endoscopic treatments, argon plasma coagulation APC and endoscopic mucosal resection EMR, to see if APC is as effective as EMR in preventing local recurrence of these small lesions measuring 1 cm or less. The study addresses current uncertainties and differing international guidelines on managing these lesions. Participants will be randomly assigned to receive either APC, which uses ionized argon gas to coagulate tissue without cutting, or EMR, which involves lifting and cutting out the lesion. EMR allows detailed pathological examination but may take longer and have more complications, while APC is simpler, quicker, and usually less invasive but lacks tissue for pathology. After treatment, all participants receive standard medical care and are monitored for any complications. Participants will return for follow-up endoscopies at 3 and 12 months to check the treated area and take biopsies if needed to detect recurrence. Researchers will record the local recurrence rate at 12 months as the main outcome, along with procedure-related complications like bleeding or perforation, procedure time, and recovery experience. The trial will provide important evidence to guide treatment choices for patients with small gastric adenomas.