Abnormal 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 Women's 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 comparing two different surgical tools, a 5 Fr bipolar electrode and a 5 Fr angled conical optical fiber for a dual wavelength diode laser, to perform hysteroscopic polypectomy in an outpatient setting. The study aims to assess procedure time, use of additional instruments, procedure effectiveness and safety, sample quality for analysis, instrument suitability, patient pain and anxiety, and changes in quality of life after treatment for women with suspected small endometrial polyps. Participants will undergo a detailed medical evaluation and pelvic ultrasound before the procedure. During outpatient hysteroscopy without anesthesia, one of the two tools will be used for polypectomy. The procedure is performed using a vaginoscopic approach with saline distension and continuous video recording. The operator will evaluate the instrument's performance, and a pathologist will assess the tissue sample quality. Pain and anxiety will be measured 20 minutes after the procedure, and patients will be observed for 30 minutes before discharge. Follow-up occurs 60 days later with another pelvic ultrasound to check for residual tissue, repeated quality of life questionnaires, and assessment of any late complications. The study measures the time to complete the hysteroscopic procedure as the primary outcome while also tracking additional instrument use, lesion removal effectiveness, adverse events, tissue quantity, instrument suitability, pain, anxiety, and quality of life over time. Women aged 18 to 60 with small suspected single polyps and specific symptoms may participate.

This research aims to collect real-world data on the Cerene Cryotherapy Device, which is used to treat heavy menstrual bleeding in premenopausal women who have completed childbearing. The goal is to compare outcomes from everyday use with those reported in earlier clinical studies, better understanding its effectiveness, safety, and usage in routine care. The study is observational and involves women receiving treatment as part of their usual care. Women enrolled in this registry will have undergone Cerene treatment according to standard care practices. The study will include up to 300 women, with no additional interventions beyond their normal medical treatment. Data will be gathered through patient and physician surveys covering demographics, quality of life, procedure details, and clinical outcomes from before treatment through 12 months after. Participants will be involved for about 13 months from enrollment to one year post-treatment. Surveys will be completed at baseline and at specified times during follow-up. Researchers will assess outcomes such as the need for further interventions, treatment location, and quality of life changes. Physician feedback and cost analysis will also be collected to provide a comprehensive understanding of the device's use in real-world settings.

Researchers are observing the safety of damoctocog alfa pegol, a medicine used to treat hemophilia A, a genetic bleeding disorder caused by missing clotting factor 8 (FVIII). This study focuses on Korean participants who are at least 12 years old and have previously used other hemophilia A treatments. The main goal is to learn more about the safety of this medicine when used in routine medical care. Participants receive damoctocog alfa pegol as prescribed by their doctors following usual clinical practices. The study does not provide the medicine directly, and no changes to healthcare or additional treatments are made for study purposes. Data collection happens continuously during a 36-week period as participants continue their regular clinic visits. During the study, researchers collect data from participants' health records and routine care without requiring extra visits or tests. They monitor for any medical problems, including adverse events, serious adverse events, and reactions related to the treatment. The study tracks bleeding episodes, medicine usage, and treatment choices over about eight months for each participant, providing real-world safety information.

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 drug’s 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 drug’s impact and safety profile. Participation involves ongoing monitoring and follow-up visits throughout the study duration.

Researchers are investigating the role of immune factors in infertile women diagnosed with adenomyosis, a condition where endometrial tissue grows into the muscular wall of the uterus. This observational study aims to understand how immune cells and molecules in the blood may affect infertility associated with adenomyosis and to find potential targets for clinical intervention to improve pregnancy outcomes. The study is sponsored by Peking University Third Hospital and follows patients undergoing in vitro fertilization-embryo transfer (IVF-ET). Participants include women aged 18 to 40 with regular menstrual cycles who have adenomyosis diagnosed by specific ultrasound criteria. The study involves collecting peripheral blood on the day of embryo transfer, and if pregnancy is confirmed at 14 days, further blood samples are collected at 21 days and every two weeks thereafter until 12 weeks of gestation. Clinical information such as age, body mass index, infertility details, hormone levels, uterine volume, and embryo transfer characteristics are also recorded. Throughout the study, researchers monitor pregnancy outcomes including clinical pregnancy rate within 10 weeks after embryo transfer, miscarriage rate within 24 weeks, and live birth rate within one year. Secondary measures include analysis of immune cells and molecules in the blood during the first 12 weeks of pregnancy. This involves regular follow-up and blood collection to explore immune changes. The total duration of participation varies depending on pregnancy status and follow-up timing.

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 evaluates the use of oral anticoagulation (OAC) combined with background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. The study aims to assess how effectively this approach prevents thromboembolic events and its safety regarding major bleeding. Patients who decline randomization may join a parallel registry to capture their treatment choices and risk profiles. Participants will be randomly assigned to one of two treatment groups: an experimental arm receiving OAC (either a vitamin K antagonist or a direct oral anticoagulant) along with antiplatelet therapy, or a control arm receiving antiplatelet therapy alone. The anticoagulation treatment lasts 90 days, and patients in the control group who experience recurrent atrial fibrillation after 30 days may switch to OAC. Follow-up includes clinic visits at 90 days and phone calls at 30, 60, and 180 days. A digital health substudy involving a wearable heart monitor for 30 days post-discharge is also offered to some participants. During the study, researchers will monitor outcomes such as death, stroke, transient ischemic attack, myocardial infarction, and thromboembolism up to 180 days after randomization, along with bleeding events at 90 days. Data collection includes medical record reviews, risk profiling, and use of anticoagulants and antiplatelets. Safety and effectiveness will be analyzed by comparing the two treatment strategies. Participation may last up to six months, with assessments conducted in person and by phone.

Researchers are evaluating two different protocols for preparing the uterus lining (endometrium) before frozen embryo transfer (FET) in women with adenomyosis undergoing IVF/ICSI. The study aims to find out if combining GnRH agonist and letrozole with hormone therapy leads to higher live birth rates compared to hormone therapy alone. It also looks at the side effects of the combined protocol. Adenomyosis, a condition where uterine tissue invades muscle layers, can cause infertility and pregnancy complications, and optimal preparation methods are unclear. Participants are randomly assigned to one of two groups. The first group receives two doses of GnRH agonist injections and daily letrozole over two months before starting hormone therapy with oral estradiol and vaginal progesterone. The second group receives hormone therapy alone starting early in the menstrual cycle with oral estradiol followed by vaginal progesterone once the uterine lining is thick enough. Embryo thawing and transfer are timed with progesterone start. Hormonal support continues until the 12th week of pregnancy. Participants undergo screening and ultrasound to confirm adenomyosis and monitor uterine lining thickness. Various pregnancy outcomes, including live birth rate at 22 weeks, pregnancy tests, implantation, miscarriage, and birth weight, are tracked. Side effects from the treatments and pregnancy complications like gestational diabetes and hypertension are also monitored. The study includes careful follow-up until delivery and newborn health assessments. Total participation duration covers preparation, pregnancy monitoring, and birth outcomes.

Heart failure is a global health issue, and left ventricular assist devices (LVADs) like the HeartMate 3 are increasingly used to improve survival for patients with advanced heart failure. Despite advances, complications related to blood compatibility, such as clotting and bleeding, remain serious concerns. This trial investigates the safety and effectiveness of using an antithrombotic regimen without aspirin in patients supported by the HeartMate 3 LVAD, building on previous findings that avoiding aspirin may reduce bleeding without increasing clotting risks. The study is a prospective, randomized, controlled trial comparing two treatment groups of advanced heart failure patients who have been supported by the HeartMate 3 LVAD for more than three months. One group will receive warfarin alone, with doses adjusted to maintain a specific blood clotting goal, while the other group will receive warfarin combined with aspirin, which is the current standard of care. Participants will be randomly assigned to one of these two antithrombotic regimens and followed over time to assess outcomes. Participants will be monitored for one year after randomization, with researchers tracking survival free from major hemocompatibility-related events like stroke, pump thrombosis, and significant bleeding. Secondary outcomes such as rates of bleeding, clotting, stroke, rehospitalization, and economic impact will also be evaluated. The study aims to enroll up to 128 patients to ensure sufficient power and includes regular follow-ups to assess safety, treatment adherence, and clinical events.