Groveland

Researchers are evaluating how effective, safe, and tolerable a vaccine for Clostridioides difficile (C. difficile) infection is in adults aged 65 years and older. The study focuses on reducing the number of C. difficile infections, which can cause diarrhea, in this older adult population. This is a Phase 3, placebo-controlled, double-blinded, randomized trial involving participants who are at risk because of recent or planned contact with healthcare systems or recent antibiotic use. Participants will receive either the C. difficile vaccine or a saline placebo. Both are given by injection into the upper arm muscle. The study includes 3 planned clinic visits and 3 phone visits initially, followed by yearly clinic visits until the study ends. Participants will remain in the study until enough infection events have occurred—this period may last up to about three and a half years, but could be shorter or longer depending on how quickly events happen or if the study stops early due to clear results. Throughout the study, participants will report any side effects such as local reactions and systemic events for 7 days after each vaccination, and adverse events for up to one month. Serious adverse events are monitored for up to 18 months after the last dose. If participants experience 3 or more loose stools within 24 hours during the study, they must save the next stool and contact the study team for infection testing. This ongoing monitoring helps assess the vaccine's impact on preventing medically attended C. difficile infections over time.

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 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 Phase 2 study focuses on patients who are also taking mood stabilizers and/or atypical antipsychotic medications. The study aims to understand differences in efficacy related to patient characteristics, while also assessing safety and tolerability. Participants will receive either ALTO-100 at a dose of 40 mg twice daily or a matching placebo tablet twice daily during the Double-Blind period. Following this, there will be an open-label treatment phase to further evaluate safety, tolerability, and effectiveness. All treatments are given alongside the patient’s existing mood stabilizer and/or atypical antipsychotic therapy. Throughout the study, participants will be regularly assessed for changes in depression symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) from Day 1 through Week 6. Researchers will monitor safety and tolerability during both the double-blind and open-label phases. The study involves ongoing compliance with assessments and procedures to track treatment effects and participant well-being.

This trial compares two supportive cancer care delivery methods for adults with newly diagnosed or recurrent solid tumor cancers. The purpose is to evaluate which approach better improves health-related quality of life and other patient-centered outcomes such as patient activation, satisfaction with care, documentation of goals, and reduction in acute care. It is a cluster-randomized comparative effectiveness study involving multiple sites assigned to different care models. One group receives technology-based supportive cancer care with weekly electronic messages or emails providing information on advance care planning and symptom management during the first four months, then every other week up to 12 months. The other group is paired with a lay health worker who discusses the same educational materials either in person or by telephone on the same schedule. Both groups receive ongoing support over the year-long intervention. Participants complete a baseline interview at enrollment and follow-up surveys at 3, 6, and 12 months. Researchers assess changes in health-related quality of life using the Functional Assessment of Cancer Therapy (FACT-G) from baseline to 3 months as the primary outcome. Secondary outcomes include patient activation, satisfaction with care, documentation of care goals, acute care use, and palliative or hospice care utilization. The study monitors participants for one year to evaluate these outcomes.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are evaluating the safety and effectiveness of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) compared to a placebo in adults recently diagnosed with SARS-CoV-2 infection who do not need hospitalization. This Phase 3, double-blind, randomized trial aims to assess participants' clinical status seven days after treatment using a five-category scale ranging from no symptoms to critical illness or death. The study also examines outcomes in two groups: those receiving other approved antiviral treatments and those who are not. Participants receive either a single 3.5-gram infusion of hIVIG or a 35-milliliter infusion of saline placebo, with equal chance of assignment to each group. The randomization is stratified by study site and whether participants are receiving standard antiviral care. The infusion occurs once, and participants are monitored thereafter to compare the effects of hIVIG plus standard care versus placebo plus standard care. During the study, participants provide written consent and agree to follow study procedures through 28 days. Researchers assess clinical status seven days after infusion and track safety and disease progression. The study excludes those with prior immune therapies or certain medical conditions and requires participants to avoid other COVID-19 treatment trials through Day 7 unless hospitalized or experiencing significant disease worsening. Clinical assessments and monitoring continue to ensure participant safety and capture outcomes related to COVID-19 illness severity.

Researchers are evaluating the effectiveness of ALTO-300 compared to a placebo when added to an antidepressant treatment in adults with moderate to severe major depressive disorder (MDD). This Phase 2 study aims to identify differences in how well ALTO-300 works based on patient characteristics. The main goal is to measure changes in depression symptoms over six weeks using the Montgomery-Åsberg Depression Rating Scale (MADRS). Participants will receive either ALTO-300 capsules or placebo capsules once daily while continuing their current antidepressant, which must be a single SSRI, SNRI, or bupropion taken for at least six weeks without recent dose changes. The study includes a randomized, double-blind phase where neither participants nor researchers know who receives the active drug or placebo. There is also an open-label extension phase after the initial treatment period. During the study, participants will undergo regular assessments to monitor their depression symptoms and overall health. Researchers will track changes in MADRS scores up to week 6 to evaluate treatment effects. Participants must comply with all study procedures, and safety will be closely monitored throughout the trial. The study includes adults aged 18 to 70 years who meet the specific inclusion criteria and do not have any exclusion conditions.