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 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.

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.

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 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 evaluating whether acupuncture, specifically the Dragon's 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 Dragon's 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 Dragon's 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 mg/kg 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.

Researchers are collecting Real-World Data (RWD) to study the ongoing safety and effectiveness of the anovo Surgical System during transvaginal gynecological laparoscopic surgeries. They are also evaluating how the anovo Skills Development Pathway affects surgeon behavior and performance, focusing on the learning curve and procedure outcomes across surgeons with different experience levels. The study aims to minimize bias by including a broad patient population. The study involves surgeons using the anovo Surgical System, an endoscopic instrument control device designed to assist in controlling instrument arms during single site, natural orifice laparoscopic-assisted transvaginal benign gynecological surgeries. The study collects data on surgery times and adverse device events, while tracking surgeon competency development through the Skills Development Pathway. Participants will be patients undergoing gynecological surgery with the anovo Surgical System. Researchers will collect data on conversion rates to other surgical approaches and monitor for unanticipated adverse device effects up to 8 weeks post-surgery. Patients will also complete post-operative questionnaires to provide additional information. This observational registry study provides ongoing safety and performance data to understand device use in real-world settings.

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.