Groveland

Researchers are evaluating the effectiveness, safety, and tolerability of a vaccine designed to reduce Clostridioides difficile C. difficile infections in adults aged 65 years and older. This phase 3 study compares the vaccine to a placebo in a group of older adults who have recent or planned contact with healthcare systems or recent antibiotic use. The purpose is to understand how well the vaccine works to prevent infections and to monitor any side effects or reactions. Participants will receive either the C. difficile vaccine or a placebo shot injected into the upper arm muscle. The study is randomized, double-blinded, and placebo-controlled. The vaccination period includes two doses and participants will be monitored for up to about three and a half years. Follow-up includes three planned clinical visits and three phone visits initially, then yearly clinic visits until the study ends. Participants are asked to report and save stool samples if they experience three or more loose stools in 24 hours to check for possible infection. During the study, researchers will track local and systemic reactions to the vaccine within seven days after each shot, adverse events up to one month after each vaccination, and serious adverse events for up to 18 months after the last dose. The main measurement is the occurrence of medically attended primary C. difficile infections from two weeks after the second vaccination through the surveillance period. Safety monitoring and annual visits will continue until the study is completed, which could be sooner or later depending on infection rates.

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase IIIII trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.

Researchers are evaluating the antidepressant effects of ALTO-100 compared to a placebo in adults with Bipolar Disorder I or II who are currently experiencing a major depressive episode. This study aims to understand how patient characteristics influence the drugs effectiveness when added to a mood stabilizer andor atypical antipsychotic treatment. The study also assesses safety, tolerability, and efficacy during an open-label treatment phase following the initial blinded period. Participants will be randomly assigned to receive either ALTO-100 40 mg tablets or a matching placebo twice daily for six weeks during the double-blind phase. Those who qualify and continue into the open-label phase will receive ALTO-100 40 mg tablets twice daily for up to seven additional weeks. The study involves careful monitoring of depressive symptoms using standardized rating scales and safety evaluations throughout both study periods. During the trial, participants will undergo regular assessments including the Montgomery-sberg Depression Rating Scale MADRS, Patient Health Questionnaire PHQ-9, and Clinician Global Impression Scale-severity CGI-S. Safety monitoring covers adverse events, vital signs like heart rate and blood pressure, weight, and suicidality using the CHRT-SR12 scale. The total study duration for each participant can extend up to 13 weeks, with close follow-up to evaluate treatment effects and safety.

Researchers are comparing two approaches to supportive cancer care for adults with cancer. This trial aims to evaluate which method better improves health-related quality of life, patient activation, satisfaction with care and decision-making, documentation of goals and symptoms, and reduces acute care use such as emergency visits and hospitalizations. The study focuses on patients with newly diagnosed or recurrent solid tumor cancers. Participants are assigned to one of two groups. One group receives educational materials about advance care planning and symptom management through technology messages weekly for the first 4 months and biweekly for months 5 through 12. The other group works with a lay health worker who discusses the same materials in person or by phone on the same schedule over 12 months. Both groups receive ongoing supportive care tailored to improve their cancer experience. Participants complete a baseline interview at enrollment by phone, followed by surveys at 3, 6, and 12 months. Researchers track changes in quality of life using the FACT-G questionnaire, patient activation, satisfaction with care and decision-making, use of palliative and hospice care, emergency visits, hospitalizations, and documentation of care goals and symptoms. The study runs through February 2028, allowing long-term monitoring of supportive care outcomes.

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.

Researchers are evaluating ALTO-300, a drug taken as a capsule once daily in the evening, for adults with moderate to severe major depressive disorder MDD. The study aims to compare the effects of ALTO-300 versus a placebo when added to an antidepressant, focusing on how patient characteristics may influence treatment outcomes. This is a randomized, double-blind trial with a phase 2 design. Participants will be randomly assigned to receive either ALTO-300 or a matching placebo capsule once daily for 42 days during the double-blind period. Those who qualify may then enter an open-label extension period lasting up to 8 weeks, during which all participants receive ALTO-300 once daily. The trial includes careful monitoring throughout both treatment periods. During the study, participants will undergo assessments to measure changes in depression symptoms using the Montgomery-sberg Depression Rating Scale MADRS up to week 6. Safety evaluations include tracking adverse events, heart rate, weight, blood pressure, and suicidality over the course of up to 15 weeks. The total participation duration may extend to 14 weeks, including both blinded and open-label phases, with regular visits and evaluations.