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Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.

Researchers are evaluating the effectiveness of active surveillance and chemotherapy treatments in pediatric, adolescent, and adult patients with low risk and standard risk germ cell tumors. This phase III trial focuses on monitoring patients after tumor removal and comparing the outcomes of carboplatin-based versus cisplatin-based chemotherapy regimens. The study aims to maintain high overall survival rates for low risk patients and to compare event-free survival between the two chemotherapy options in standard risk patients. Additional objectives include assessing side effects such as hearing loss and neuropathy, and exploring tumor marker changes and other biological measures related to treatment outcomes. Patients with low risk stage I germ cell tumors undergo surgery followed by observation, with the option to transfer to standard risk treatment if the tumor recurs. Those with standard risk tumors are randomly assigned to one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin. Treatments are given intravenously on specific schedules every 21 days for up to 3 or 4 cycles, depending on the group. Throughout the trial, patients receive imaging scans, blood tests, tumor biopsies if needed, and pulmonary function tests to monitor treatment response and side effects. Participants are closely followed after treatment completion with regular visits every 2 months for the first year, then less frequently up to 10 years. Researchers collect data through imaging, blood samples, lung tests, and questionnaires to measure survival, disease recurrence, and side effects like hearing loss. The study also includes exploratory analyses of tumor markers and patient-reported outcomes to better understand treatment impacts and improve future care for germ cell tumor patients.

Researchers are evaluating the effects of adding cemiplimab, an immunotherapy drug that blocks the PD-1 pathway to help the immune system attack tumor cells, to the usual treatment of docetaxel and ramucirumab in patients with stage IV or recurrent non-small cell lung cancer. This phase II/III Expanded Lung-MAP trial compares cemiplimab combined with docetaxel and ramucirumab versus docetaxel and ramucirumab alone, aiming to improve treatment outcomes in patients who previously received platinum chemotherapy and immunotherapy but developed resistance or disease progression. Participants are randomly assigned to one of two treatment arms. In Arm I, patients receive dexamethasone orally twice daily on days 0-2, ramucirumab and docetaxel intravenously on day 1 of each 21-day cycle. In Arm II, patients receive the same treatments plus cemiplimab intravenously on day 1 of each cycle. Treatment cycles continue every 21 days until disease progression or unacceptable side effects occur. Throughout the study, patients undergo regular blood sample collection and imaging scans such as CT or MRI to monitor disease status. During the study, participants are closely monitored with scans, blood tests, and physical exams to assess overall survival and other outcomes like progression-free survival, response rates, and treatment safety. Researchers also collect blood samples for future molecular studies. After completing treatment, patients are followed up every 3 to 6 months for up to 3 years to track long-term survival and health status. The study measures overall survival from randomization to death from any cause, assessed up to 3 years.

Researchers are evaluating a computerized treatment called CAST (Computerized Anxiety Sensitivity Treatment) compared to a health education control (HEC) in older adults who have mild cognitive impairment (MCI) or mild Alzheimer's Disease and related dementias (ADRD) along with their care partners. The study aims to find out if CAST can reduce anxiety and related symptoms in these older adults and lessen the burden on their care partners. The study also explores how the treatment works by using various assessments related to anxiety sensitivity and anxiety. Participants join as pairs (dyads) consisting of the older adult with MCI or mild ADRD and their care partner. They are randomly assigned to either the CAST group or the HEC group. CAST involves viewing presentations and completing exercises focused on anxiety sensitivity with guidance from an interventionist. The HEC group views presentations about healthy behaviors and completes behavior tracking and goal setting with an interventionist. The study includes two intervention sessions and six in-person visits in total. Participants complete baseline testing including cognitive evaluations and questionnaires, and use an app for ecological momentary assessments (EMAs) for three separate weeks: one week before the first intervention, between the two intervention sessions, and one week after the second session. Follow-up assessments occur at 1, 3, and 6 months after treatment to measure changes in anxiety and cognitive function. Researchers monitor changes in anxiety sensitivity and anxiety from before treatment to immediately after and at 1-month follow-up.

Researchers are evaluating a new type of spectacle lens to control myopia progression in children aged 6 to 8 years. This randomized, controlled, multisite trial aims to confirm findings from previous studies and predict treatment effects over three years by assessing efficacy at 12 months. The study focuses on juvenile myopia and its progression. Participants are randomly assigned to one of two groups: one group uses a novel single vision, impact-resistant spectacle lens designed to reduce myopia progression, while the other group wears standard single vision, impact-resistant spectacle lenses. Both groups wear their assigned spectacles daily, except during sleep, swimming, or activities where wearing glasses is unsafe. The study runs for 24 months without allowing contact lens use. Children will undergo various eye measurements including visual acuity, axial length, and refractive error assessments at baseline and during follow-up visits. Researchers will measure spherical equivalent refraction after 12 months to evaluate treatment efficacy. Parents or guardians must consent and commit to the full study duration, ensuring adherence to spectacle wear and study procedures. The trial monitors safety and effectiveness through regular eye exams and data collection over two years.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the effectiveness and visual symptoms of the MiSight 1 Day contact lens in children aged 8 to 12 years with myopia. The study aims to confirm the lens's ability to slow the progression of myopia in clinical practice in the US and assess how stable the reduction in myopia remains after one year without treatment. This is a multicenter, randomized, double-masked clinical trial lasting four years, divided into two parts. In Part 1, participants are randomly assigned to wear either MiSight 1 Day lenses or Proclear 1 Day lenses for three years to compare their effects on myopia progression. In Part 2, all participants wear Proclear 1 Day lenses for one additional year to study the stability of the myopia control after stopping the MiSight lenses. Both participants and investigators remain masked to the treatment assignments from Part 1. Participants will attend scheduled visits for eye examinations including measurements of spherical equivalent refractive error and axial length. Researchers will monitor visual acuity, eye health, and myopia progression over the four-year period. The main outcomes measured are the changes in refractive error and axial length after three years and the rate of change during the one-year post-treatment period. Participants are expected to wear the lenses about 10 hours daily, six days per week, and maintain follow-up visits throughout the study.

Researchers are investigating whether observation is as effective as continuing pembrolizumab treatment in patients with early-stage triple-negative breast cancer who achieved a complete response after preoperative chemotherapy combined with pembrolizumab. This phase III trial aims to evaluate recurrence-free survival and quality of life, as well as the value of reducing immunotherapy treatment after surgery in these patients. The study also examines differences in adverse events, overall survival, and financial impacts between treatment approaches. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group receives pembrolizumab intravenously as adjuvant therapy, while the other group undergoes observation without further treatment. Both groups have tumor biopsies and blood samples collected on study and during follow-up. Additional assessments include questionnaires and quality-of-life evaluations. During the study, researchers monitor participants for up to 10 years to measure recurrence-free survival. They assess quality of life using validated tools, track adverse events, and evaluate financial toxicity and work productivity. The study includes tumor tissue analysis, blood sample collection, and patient-reported outcomes to understand the long-term effects and value of treatment de-escalation in breast cancer care.

Researchers are studying the effects of Tai Chi on older adults aged 60 and above, including those with Mild Cognitive Impairment (MCI) and those without cognitive impairment. The study aims to understand how heart rate variability, brain activity, pain interference, social isolation, muscle loss (sarcopenia), and obesity relate to cognitive function. The focus is on how these factors influence cognitive health before and after an 8-week Tai Chi program. Participants will take part in an 8-week Tai Chi program based on the Harvard Medical School Guide to Tai Chi. This includes weekly 75-minute in-person classes led by the principal investigator, with additional video sessions and a workbook to support home practice. The program introduces Tai Chi principles, warm-up exercises, Tai Chi movements, and cool-down exercises. Virtual live sessions are available for those unable to attend in person. During the study, participants' cognitive function will be assessed using tests like the Stroop Color-Word Interference Test and Semantic Fluency Test from enrollment to the end of treatment at 8 weeks. Researchers will also monitor heart rate variability, brain activity, and psychosocial factors such as pain and social isolation. The study evaluates how sarcopenia and obesity might predict changes in cognitive function over the course of the intervention.