Mankato

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 evaluating the long-term effects of aleniglipron, a drug taken orally, in adults with overweight or obesity who also have type 2 diabetes mellitus T2DM. This is a randomized, double-blind, placebo-controlled Phase 3 study designed to assess the drugs effectiveness, safety, and tolerability over an extended period. The study focuses on the management of weight and diabetes in this population. Participants will be randomly assigned to receive either aleniglipron or a placebo, all administered orally. The treatment period lasts for 76 weeks, during which participants will take multiple doses of the assigned medication. The study includes three different aleniglipron arms and one placebo arm, all aiming to evaluate weight change and diabetes control over time. Throughout the study, participants will undergo assessments to measure changes in body weight, waist circumference, HbA1c levels, blood pressure, and cholesterol levels. The primary outcome is the percent change in body weight from the start of the study to week 76. Secondary outcomes include the proportion of participants achieving various levels of weight loss and diabetes targets. The study also monitors safety and tolerability during the treatment period, which lasts approximately 76 weeks.

Researchers are evaluating whether an anesthetic called Lidocaine may be effective when injected around the sciatic nerve of the intact limb in patients experiencing pain in the opposite limb after limb loss. This study focuses on people with phantom limb pain or residual limb pain who have undergone lower extremity amputation more than a year ago. The trial is a double-blind, randomized controlled study to assess pain relief and functional improvement. Participants will be randomly assigned to receive either a 2% lidocaine injection or a saline placebo injection in the back of their residual limb. The study compares these two treatments to understand their effects on pain and function. The trial is scheduled to start in June 2024 and will monitor participants shortly after injection and for several days following treatment. During the study, participants will be assessed for changes in pain levels at baseline and 60 minutes after injection, as well as changes in functional ability and disability five days post-injection. Additional measurements include pressure-pain sensitivity and step counts five days after treatment. Researchers will closely monitor participants and collect data related to these outcomes to evaluate the impact of the injections over time.

Researchers are evaluating a new medication called CX11 for adults with type 2 diabetes who have not achieved adequate blood sugar control despite taking a stable dose of metformin, with or without an SGLT2 inhibitor, for at least 90 days. This phase 2 study is randomized, double-blind, and placebo-controlled, aiming to determine the safety and effectiveness of different doses of CX11 in comparison to placebo. Participants will be randomly assigned to one of six groups, each receiving a different dose of CX11 40 mg, 80 mg, 120 mg, 160 mg, or 200 mg or a matching placebo. The medication is taken orally once daily for 24 weeks, followed by a 2-week safety follow-up period. The study is conducted across multiple medical centers and neither participants nor staff will know the group assignments during the trial. Throughout the study, participants will undergo regular assessments including blood tests to measure changes in HbA1c a marker of blood sugar control, fasting plasma glucose, body weight, and blood pressure. Continuous glucose monitoring will track time spent in the target glucose range. Safety is monitored by recording adverse events and measuring plasma drug levels at specified intervals. The total participation period is approximately 26 weeks.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are studying the immediate and long-term effects of structured breathing exercises on mental health symptoms such as anxiety, depression, stress, and sleep quality. The study focuses on healthcare professionals experiencing burnout and aims to assess how these breathing practices might support their mental well-being. This behavioral intervention is sponsored by Mayo Clinic and targets adults aged 18 to 85 years. Participants will engage in self-guided structured breathing sessions lasting 15, 30, or 36 minutes, tailored to their personal skill level. The study monitors the feasibility, acceptability, and appropriateness of these breathing exercises over a four-month period. The intervention is delivered via a mobile app, allowing participants to practice breathing exercises on their own schedule. During the study, participants will be assessed on recruitment ease, retention, mobile app engagement, satisfaction with the breathing intervention, and adherence to the program. Researchers will collect data through mobile app usage metrics and self-reported measures to evaluate how well the intervention fits into the participants routines. The total participation time for each individual is four months, during which their progress and experience with the breathing practice will be closely monitored.

Researchers are evaluating the safety of an investigational varicella vaccine VNS Vaccine compared to an approved varicella vaccine called Varivax. This study focuses on healthy children aged 12 to 15 months who have not had chickenpox or received any varicella vaccine before. The goal is to understand how well the new vaccine is tolerated in this young population. Participants will receive one dose of either the investigational varicella vaccine or the marketed Varivax vaccine, both given by injection under the skin. Along with the varicella vaccine, each child will also receive one dose each of measles, mumps, and rubella MMR vaccine, hepatitis A vaccine, and a pneumococcal conjugate vaccine PCV, which may be PCV 13, Vaxneuvance, or PCV 20, depending on availability and national recommendations. All vaccines are given on the first day of the study. During the study, parents will record any side effects their child experiences, particularly those related to the injection site or systemic symptoms like fever, for up to 43 days. Researchers will monitor any adverse events, including serious and medically attended events, for up to 181 days after vaccination. This helps assess the safety and tolerability of the investigational vaccine over a period of about six months.

This research investigates the impact of a team-based kidney care program on adults who have survived moderate to severe acute kidney injury AKI after a hospital stay. The study aims to evaluate how this multidisciplinary approach affects patient-centered outcomes compared to usual care. The goal is to improve recovery and prevent complications after hospital discharge by providing tailored support based on individual risk. Participants are assigned to one of two groups. The intervention group receives risk-based kidney care before leaving the hospital, which may include education, referrals to primary care with medication reviews, or nephrologist-led care combined with remote monitoring for up to 90 days post-discharge. The usual care group receives standard education, laboratory tests, and clinical follow-up after discharge. This pragmatic trial compares these approaches to assess their effects on health outcomes. During the study, participants are monitored for hospital-free days over 90 days, 180 days, and one year. Researchers also track hospital readmissions, death, kidney function changes, recurrence of AKI, chronic kidney disease progression, and cardiovascular events. Follow-up evaluations include laboratory tests, medication reviews, and specialist consultations. The research spans up to one year to assess the long-term effects of the kidney care program on patient health and recovery.

Researchers are evaluating quality of life differences in men with localized prostate cancer treated with two different radiation therapies. The study compares near margin-less adaptive radiation therapy ART, which adapts treatment based on information gathered during therapy and uses smaller margins to limit radiation to healthy tissue, against standard stereotactic ablative body radiotherapy SABR, a precise external radiation delivered over several days. The goal is to see if the shorter ART treatment can provide similar cancer control with fewer side effects impacting quality of life. Participants are randomly assigned to one of two groups one receives near margin-less ART in 2 treatments spaced at least 3 days apart, including imaging with cone beam CT and possibly CT or MRI scans the other receives standard SABR in 5 treatments spaced at least 2 days apart, with CT or MRI imaging. Treatments continue only if there is no disease progression or unacceptable side effects. After treatment, participants are followed with visits at 1, 3, and 6 months, then every 6 months for up to 5 years. Throughout the study, participants complete questionnaires assessing early and late changes in bowel and urinary quality of life, financial impact, erectile function, and prostate symptoms. Researchers also monitor physician-reported toxicities, biochemical markers of cancer progression, and survival. Imaging and dosimetry data are collected to explore treatment effects. This thorough monitoring aims to capture both patient experiences and clinical outcomes over up to 5 years.

Researchers are evaluating the effects of high dose intravenous ascorbic acid combined with chemotherapy in patients with relapsed or refractory lymphomas, clonal cytopenia of undetermined significance CCUS, and chronic myelomonocytic leukemia CMML. This phase II trial aims to determine how ascorbic acid added to standard chemotherapy affects response rates, safety, and survival outcomes compared to chemotherapy alone. The study also explores biological markers related to oxidative stress and DNA methylation to better understand treatment effects. Participants are assigned to different treatment arms based on their disease type. Some receive intravenous ascorbic acid plus combination chemotherapy every 21 days for up to 4 cycles, while others receive placebo with chemotherapy or ascorbic acid alone with varying schedules. Specific regimens include drugs such as rituximab, ifosfamide, carboplatin, etoposide, decitabine, and others, administered intravenously or orally. Some patients undergo stem cell transplantation based on their response. The study includes procedures like blood sample collection, biopsies, echocardiography, PETCT or MRI scans, and central venous line placement. During the study, participants undergo regular assessments to monitor treatment response and side effects. These include imaging scans, bone marrow biopsies, and blood tests to evaluate overall response rates and hematologic improvements. Follow-up visits occur every 3 months initially, then every 6 months after disease progression for up to 2 years. Researchers also collect patient-reported outcomes and monitor safety events throughout the study period to better understand the impact of the treatments being tested.