Mount Airy

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

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 evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are studying whether a virtual exercise program can be successfully delivered to cancer patients undergoing chemotherapy. The goal is to help patients exercise at home through telehealth video calls, which may reduce side effects like fatigue and loss of strength that affect daily activities. This trial focuses on diverse patients receiving curative chemotherapy and aims to evaluate the programs feasibility and impact on physical function and activity. Participants will engage in supervised telehealth exercise sessions twice weekly, combining aerobic and progressive resistance exercises, alongside unsupervised aerobic exercises totaling about 50 minutes per week. They will receive equipment such as a stationary bike, workbook, gloves, and resistance bands, and wear an accelerometer to monitor activity. The program continues until the end of standard chemotherapy or up to six months unless disease progression or toxicity occurs. Throughout the study, participants will be assessed on exercise session completion and retention rates over six months. Physical function tests like the 6 Minute Walk Test and grip strength will be measured at baseline and post-intervention. Patient-reported outcomes and employment status will also be tracked at baseline, end of intervention, and three months later. Follow-up visits occur at 4 weeks and 3 months after completing the exercise program to monitor continued effects and adherence.

Researchers are evaluating the effectiveness and safety of fusidic acid 1% eye drops compared to a placebo for treating bacterial conjunctivitis in both adults and children. This Phase 3 clinical trial aims to show that fusidic acid 1% is superior to placebo in curing bacterial conjunctivitis and to further confirm its safety when applied topically to the eyes. Participants will be randomly assigned to one of two groups one group will apply one drop of fusidic acid 1% in each eye twice daily for seven days, and the other group will use a placebo eye drop with the same schedule. The doses are ideally spaced about 12 hours apart, but the twice-daily application schedule is prioritized over exact timing. During the study, participants will be assessed for clinical cure and microbial eradication at Day 4 and Day 8 visits. Researchers will monitor safety and treatment effects through these evaluations and by tracking any adverse events. The total participation duration covers at least the seven days of treatment plus follow-up assessments, helping establish both effectiveness and safety profiles for the treatment.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are evaluating the impact of geriatric evaluation and management combined with survivorship health education GEM-S compared to usual care on physical function in older cancer survivors. This phase III trial aims to improve how older adults who have survived cancer manage daily activities, mental well-being, and memory after chemotherapy. The study also seeks to understand how such care affects the quality of life for both cancer survivors and their caregivers. Participants are assigned to one of two groups based on their practice site. One group receives routine follow-up care from their doctors over three visits within six months. The other group takes part in a one-hour GEM consultation discussing geriatric assessment results and recommendations, attends survivorship health education sessions twice weekly for four weeks, and participates in a daily walking and resistance exercise program called EXCAP. Both survivors and their caregivers are involved in these activities. Throughout the study, participants complete patient-reported assessments on physical and cognitive function, objective tests like a 6-minute walk and cognitive exams, and questionnaires about satisfaction with care and coordination. Caregiver distress and quality of life are also measured. Follow-up continues for six months after the interventions to monitor outcomes and gather data on the effects of the GEM-S approach.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

This trial studies adults with advanced non-small cell lung cancer NSCLC that has spread outside the lungs and has specific mutations in the EGFR gene. Researchers are comparing two treatment approaches osimertinib alone versus osimertinib combined with bevacizumab. The study aims to evaluate how these treatments affect the time patients live without disease progression and overall survival, as well as their effects on brain metastases and treatment safety. Participants are randomly assigned to one of two groups. One group receives osimertinib pills daily every 21 days, while the other group receives osimertinib daily plus an intravenous infusion of bevacizumab every 21 days. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants undergo tests including echocardiography, MUGA scans, CT scans, and possibly MRI, along with blood and urine sample collection. After treatment ends, participants are followed every three months for up to 10 years to monitor disease status and survival. Researchers will assess progression-free survival, overall survival, response rates, time to brain progression, and side effects. The study includes long-term follow-up to understand the lasting effects of these treatments and to explore resistance mechanisms through tumor DNA analysis.

Researchers are evaluating whether simply observing patients after surgery is as effective as continuing pembrolizumab treatment in preventing cancer recurrence in people with early-stage triple-negative breast cancer TNBC who had a complete response after receiving chemotherapy plus pembrolizumab before surgery. This Phase III trial aims to determine if stopping pembrolizumab post-surgery can maintain recurrence-free survival while potentially improving quality of life and reducing treatment burden. Participants are randomly assigned to one of two groups after finishing chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab intravenously every 3 or 6 weeks for 27 weeks. The other group undergoes observation without further pembrolizumab for the same period. Throughout the study, patients have tumor biopsies and blood collected, along with imaging such as mammography, breast ultrasound, or MRI during follow-up. Participants will be monitored for recurrence-free survival and overall survival for up to 10 years. The study also assesses adverse events, quality of life, financial impact, and work productivity at about 27 weeks after starting the assigned treatment or observation. Safety and treatment effects are tracked through biopsies, imaging, blood tests, and patient questionnaires during the study and follow-up.