Dysfunctional Uterine Bleeding

Researchers are evaluating the use of inhaled Methoxyflurane, a short-acting and self-administered pain reliever, to improve comfort during intrauterine device IUD insertion. This trial focuses on women aged 18 to 55 undergoing IUD insertion, aiming to assess whether 3 mL of Methoxyflurane can reduce pain and anxiety and improve patient satisfaction compared to a placebo. The study is a double-blind, randomized controlled trial sponsored by Womens College Hospital. Participants are randomly assigned to receive either a Penthrox inhaler with 3 mL of Methoxyflurane or an identical inhaler containing saline as a placebo. Both groups follow a self-inhalation schedule before speculum insertion and may continue as needed during the procedure. Standard pain management is also provided, including recommendations for over-the-counter pain relievers and the option for a cervical block to help reduce discomfort. During the study, participants will be monitored for pain intensity, anxiety, distress, and satisfaction with pain management at various times before, during, and after the procedure, including up to 24 hours later. Researchers will also track any adverse effects or emergency visits. The main outcome is procedural pain intensity measured 20 minutes after the procedure, with additional assessments of patient and provider satisfaction and the effectiveness of blinding. The trial is expected to run until February 2027.

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 observing people with hemophilia A, a genetic bleeding disorder caused by a lack of clotting factor 8 FVIII, who use the drug damoctocog alfa pegol as prescribed by their doctors. The study aims to learn more about the safety of this drug in Korean participants who have previously used other hemophilia A treatments. Hemophilia A can cause excessive bleeding after injury or surgery, and damoctocog alfa pegol replaces the missing FVIII to help prevent or treat bleeding episodes. Participants will continue their usual treatment with damoctocog alfa pegol during routine medical care, following approved product guidelines. No study drug is provided by the researchers, and no changes to healthcare are made for study purposes. Data collection occurs over about 8 months for each participant, from December 2023 to March 2026, with information gathered from health records and routine clinic visits. Participants are involved through their regular medical visits, with no extra tests or visits required for the study. Researchers will monitor and collect data on any medical problems, including various types of adverse events and reactions, during treatment. They will also track bleeding episodes and treatment use, comparing with previous FVIII products. Safety data will be collected continuously during the 36-week observational period without interfering with standard care.

This observational study aims to understand how force feedback instruments are useful during surgeries performed with the da Vinci 5 robotic system. It focuses on procedures such as inguinal and ventral hernia repairs, colorectal, thoracic, gynecologic surgeries, and partial nephrectomy. The study is designed to gather information on how these instruments perform during robotic-assisted surgery. Participants will undergo multi-port robotic-assisted surgery using the da Vinci 5 system equipped with force feedback instruments, which provide tactile sensations. The study observes surgeries planned as primary procedures with these instruments, without altering the treatment. There is no experimental drug or placebo involved, as this is an observational study conducted after the devices have been marketed. During the study, researchers will measure the force applied to tissues by the force feedback instruments during surgery and evaluate how useful these instruments are during specific steps of the procedure before patient discharge. Participants will be followed up as per the study protocol to ensure data quality. The total participation time varies depending on the surgical procedure and follow-up schedule.

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 whether acupuncture, specifically the Dragons protocol, can help reduce chronic pelvic pain in women aged 21 to 65. This study focuses on non-endometriosis pelvic pain and includes women both with and without a history of sexual assault. The Dragons protocol acupuncture aims to address both physical pain and emotional trauma by combining external and internal acupuncture treatments to reprocess traumatic memories and potentially calm the nervous system. Participants will first undergo 4 weeks of standard pain care such as physical therapy, psychotherapy, or usual medical management. Then, the same women will receive acupuncture treatments once weekly for 4 weeks using the Dragons protocol. The acupuncture involves placing needles on both the back external dragons and front internal dragons of the body during each session, aiming to balance traumatic memories and pain responses. Throughout the study, participants will complete pain assessments using the Defense and Veterans Pain Rating Scale DVPRS and the Female Genitourinary Pain Index GUPI at multiple visits from week 0 to week 11. Women with a history of sexual trauma will also complete the PTSD Checklist for DSM-5 PCL-5 to evaluate changes in PTSD symptoms. Visits include screening, baseline, weekly acupuncture sessions, and follow-ups, some of which may be virtual. Researchers will monitor pain levels and quality of life to understand the impact of the acupuncture treatment.

Researchers are evaluating the combination of adebrelimab and fuzuloparib in people with recurrent platinum-resistant ovarian cancer who have not received previous systemic antitumor therapy for this cancer. This exploratory, single-arm Phase 2 study focuses on assessing the effectiveness and safety of this drug combination in women with this condition. The study is led by Fujian Cancer Hospital and aims to measure outcomes over a 3-year period. Participants receive adebrelimab at 20 mgkg intravenously every three weeks and take fuzuloparib orally at 100 mg twice daily. The study does not include a comparator group and follows a single treatment approach. Treatment continues under medical supervision while researchers monitor the participants response and safety. During the study, participants undergo regular evaluations including scans to measure tumor response using RECIST1.1 criteria, blood tests, and physical assessments. Researchers track the primary outcome of objective response rate over three years, along with secondary outcomes like overall survival, progression-free survival, and disease control rate. Safety monitoring and adherence to study procedures are maintained throughout the study, with participation lasting up to three years.

Uterine fibroids are benign smooth muscle tumors of the uterus that are part of a broader group including malignant tumors with varying severity. Magnetic resonance imaging MRI is commonly used to differentiate fibroids from malignant tumors, but it has limitations that can lead to inappropriate treatment. This study aims to validate a new minimally invasive biopsy technique called ultrasound-guided transuterine vaginal biopsy BVTE to improve preoperative diagnosis and avoid unnecessary or harmful surgeries for uterine smooth muscle tumors. The procedure involves performing the BVTE under general anesthesia on the day scheduled for myomectomy or hysterectomy. The biopsy targets the center of the tumor via a transuterine route to reduce the risk of spreading cancer cells, taking 4 to 5 samples per tumor with a maximum of three tumors sampled. After the biopsy, patients undergo the planned surgery during the same operation, and all surgical specimens are sent for anatomopathological analysis. Participants will be assessed through anatomopathological comparison of the biopsy samples with the reference surgical specimens throughout the study period of 43 months. Researchers will monitor intraoperative and postoperative complications using the Clavien-Dindo classification. This study evaluates the feasibility, safety, and diagnostic accuracy of the BVTE technique as part of current clinical practice for women requiring surgical treatment for uterine smooth muscle tumors.

This research aims to assess the effectiveness and safety of adding oral anticoagulation OAC to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation POAF after isolated coronary artery bypass graft CABG surgery. The study is a prospective, multicenter, open-label, randomized trial comparing OAC with no OAC to evaluate the prevention of thromboembolic events and the risk of major bleeding. Participants are randomly assigned to either an OAC-based strategy using vitamin K antagonists or approved direct oral anticoagulants alongside antiplatelet therapy, or to an antiplatelet-only strategy. The anticoagulation treatment lasts for 90 days, with option for crossover to OAC if recurrent atrial fibrillation occurs after 30 days in the control group. Up to 500 patients may also participate in a digital health substudy using a wearable heart rhythm monitor for 30 days post-discharge. During the study, participants have follow-up visits at 30, 60, 90, and 180 days after randomization, including phone contacts and clinical assessments. Researchers will monitor outcomes such as death, stroke, transient ischemic attacks, myocardial infarction, thromboembolism, and bleeding events up to 180 days. Data from patients who decline randomization are collected in a parallel registry to compare baseline risk and treatment strategies.

Researchers are conducting an observational study to improve understanding of the menstrual cycle and various gynecologic health conditions such as polycystic ovary syndrome PCOS, infertility, and breast cancer. This study focuses on reproductive health and menstrual patterns in women and aims to gather long-term data to describe these aspects epidemiologically. The study is hosted on the Apple Research app, which participants can use to find, enroll in, and take part in this research. It collects data related to menstrual cycle patterns and the prevalence of gynecologic health conditions over a period of up to 10 years. Participants will engage through the app, providing information about their menstrual cycles and health conditions. The study tracks menstrual cycle patterns and collects epidemiologic data over time, also determining the prevalence of related health issues. This observational approach allows long-term monitoring without administering treatments. The study is expected to continue through November 2029.