Huntington

Researchers are studying two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 genetic mutations. This trial compares bilateral salpingectomy, which removes only the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The goal is to find out if removing just the fallopian tubes with delayed ovary removal is nearly as effective as removing both from the start. Participants choose between two groups one undergoes bilateral salpingectomy with the option of later ovary removal, and the other undergoes bilateral salpingo-oophorectomy. Both groups have imaging tests like pelvic ultrasounds or pelvic MRIs during screening and provide blood samples throughout the study. Follow-up visits occur at multiple time points, including 10 to 60 days, 6 months, 12 months, 24 months, and then yearly for up to 20 years. During the study, researchers track if ovarian or related cancers develop and assess symptoms related to estrogen loss, quality of life, cancer-related distress, sexual function, menopausal symptoms, medical decision making, and any adverse events. Various questionnaires and imaging tests support these evaluations. Long-term safety and cancer risk reduction are monitored for up to two decades after surgery.

Researchers are conducting a randomized controlled trial to compare survival outcomes between robotic-assisted laparoscopy and open hysterectomy with lymph node assessment for early-stage cervical cancer. The study aims to determine if robotic hysterectomy with tumor containment before colpotomy is not worse than abdominal hysterectomy in terms of disease-free survival. It includes patients with specific cervical cancer stages and tumor sizes suitable for surgery. Participants will undergo either a radical or simple hysterectomy using either traditional open surgery or a robotic-assisted technique. In the robotic group, the vagina is closed before colpotomy, and certain vaginal manipulators are not allowed. Both groups may have salpingectomy and oophorectomy with or without ovarian transposition. Surgeons will document operative details, including any complications, blood loss, and reasons for conversion to open surgery. During the trial, participants will be closely monitored with preoperative assessments like labs, EKG, and MRI to confirm eligibility. Surgical findings and complications will be recorded. The primary outcome measured is survival at 36 months. Participants must provide informed consent and undergo follow-up to assess disease status and survival over the study period, which extends until 2030.

Researchers are tracking patients with Fabry disease through an ongoing international observational program called the Fabry Registry. This registry collects routine clinical outcomes for patients regardless of whether they are receiving treatment. The study aims to better understand the diseases variability, progression, and natural history, including in women who carry one copy of the gene, and to help improve patient care by developing monitoring recommendations and reporting outcomes. Additionally, the registry evaluates the long-term safety and effectiveness of Fabrazyme4, a treatment used in Fabry disease. The registry includes a special pregnancy sub-registry for women with Fabry disease who are pregnant or have been pregnant. This sub-registry observes pregnancy outcomes and infant growth up to 36 months after birth, collecting medical and obstetric history and treatment details. No experimental treatments are given participants continue to receive their usual care as determined by their physicians. Data from both registries support regulatory requirements and ongoing research. Participants undergo regular clinical assessments and receive standard care from their doctors throughout the study. The research team collects data on disease progression, treatment effectiveness, pregnancy outcomes, and infant development. The study is observational, meaning no study drugs or procedures are administered. The total participation can last up to 33 years, allowing for long-term monitoring of safety and outcomes related to Fabry disease and pregnancy.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

This research aims to collect detailed information about Pompe disease, a rare genetic disorder also known as Glycogen Storage Disease Type II. The study is a global, long-term observational program designed to better understand the diseases progression, variability, and identification in patients who are either treated or untreated. It also supports regulatory requirements, product development, reimbursement, and other research purposes. Participants in the Pompe Registry are tracked over many years, up to 30 years, to observe the natural history of the disease and evaluate long-term outcomes, including the effects of treatments like alglucosidase alfa. This observational study does not involve experimental treatments but gathers data from patients worldwide to improve care strategies and recommendations. During the study, participants health information is collected retrospectively and prospectively, including clinical outcomes and disease manifestations. Researchers analyze these data to understand patient variability, disease progression, and treatment effectiveness. The registry helps develop guidance for monitoring patients and provides valuable insights to optimize Pompe disease care over an extended period.

Researchers are evaluating the long-term performance and reliability of Medtronics market-released cardiac rhythm therapy products, including leads and devices used for pacing, sensing, or defibrillation. This observational study aims to analyze how well these cardiac devices function over time by measuring survival probabilities and tracking device-related complications. The study applies to patients with conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. The study includes all Medtronic market-released cardiac leads and implantable devices such as pacemakers IPG, implantable cardioverter defibrillators ICD, and cardiac resynchronization therapy CRT devices. Participants either have a new implant or are within 30 days post-implantation. Data from prior qualifying Medtronic studies with complete follow-up may also be included. The study continuously monitors these products from the time of implant until the lead is no longer in use due to patient exit, death, or device deactivation. Participants provide consent for data access and use, and their health information is tracked over the long term. Researchers evaluate lead-related complications and product survival throughout the study period, which began in 1983 and is ongoing until 2040. The study does not involve additional treatments but collects follow-up data to assess device performance and safety over time.

This registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.

Researchers are studying adults with sinus node dysfunction who receive a single chamber atrial leadless pacemaker to understand several important outcomes. The study evaluates the rate of new atrial fibrillation occurring in these patients, the need to upgrade from a single chamber atrial leadless pacemaker to a dual chamber system, and compares the battery life of the Aveir AR pacemaker at two years with that of dual chamber leadless pacemakers from another study. This observational study is sponsored by Northwell Health and is focused on patients with specific heart rhythm conditions. Participants receive standard care including implantation of an atrial leadless pacemaker and an implantable loop recorder device for continuous heart rhythm monitoring. The loop recorder helps detect atrial fibrillation and other heart conduction changes over time. The study does not involve experimental treatments but closely observes patients with this device for up to 24 months to assess device performance and clinical outcomes. During the study, participants will be monitored for the development of atrial fibrillation, changes in heart conduction intervals, and any need to upgrade their pacemaker system. Battery longevity of the device will also be tracked over two years. Data collection includes heart rhythm recordings from the loop recorder and clinical assessments. Participants progress is followed regularly to measure these outcomes and ensure safety throughout the study period, which lasts until the end of 2029.