Mankato

This study consists of 2 week screening period in which subjects who have consented will be evaluated for eligibility per protocol requirements. During this 2 week screening period subjects will be given access to ediary in which they will be required to self report symptoms of IBS-C daily. Information in ediary will also be used to determine eligibility prior to enrollment. During the 4 week RTP (Randomized treatment period), subjects will be randomized in in a ratio of 5:1 to receive tenapanor or matching placebo for 4 weeks. During the RTP, patients will continue recording daily assessments in the eDiary system as instructed and compliance with eDiary entries will be monitored. Patients will return for study visit every weeks (Visits 3-6) and will undergo safety assessments as per the protocol. At the end of this 4 week period, subjects will complete 2 week treatment free follow-up period and safety assessments per protocol will be conducted at the end of this 2 week period. The study plans to enroll up to 6 cohorts of eligible patients sequentially, starting from Cohort 1 with 12 patients randomized in to receive tenapanor 2 mg BID or matching placebo for 4 weeks. Subsequent cohorts will assess increasing tenapanor doses, following a dose escalation order. The study will proceed to the next dosing cohort if the current cohort completes the 4-week RTP and does not meet any of the dose escalation stopping criteria pre-specified in the protocol.

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

This research aims to determine if injecting an anesthetic called Lidocaine around the sciatic nerve of the intact limb can help reduce pain on the opposite side in patients who have lost a limb and experience phantom or residual limb pain. The study focuses on patients with lower extremity amputation and persistent limb pain that has not improved with conservative treatments. This is a Phase 4, double-blind, randomized controlled trial investigating the effectiveness of this approach compared to a placebo. Participants will receive either a 2 teaspoons injection of 2% Lidocaine or a saline injection as a placebo around the sciatic nerve of the intact limb. The treatment is given as a nerve block guided by imaging to target the specific nerve. The goal is to assess whether this injection reduces pain and improves function in the affected amputated limb. During the study, researchers will measure changes in pain levels before and 60 minutes after the injection, as well as functional improvement from baseline to 5 days after injection. Participants will be monitored for pain relief and any side effects. The study requires patients to have had an amputation for more than a year and persistent pain despite prior treatments, and participation involves a diagnostic nerve block procedure and follow-up assessments over several days.

Researchers are evaluating the safety and effectiveness of a new medication called CX11 in adults with type 2 diabetes who have not achieved good 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 conducted at multiple medical centers and uses a randomized, double-blind, placebo-controlled design to compare different doses of CX11 against placebo over a 24-week treatment period. Participants will be randomly assigned to one of six groups, each receiving a different dose of CX11 tablets or matching placebo tablets taken orally once daily. The treatment phase lasts 24 weeks, followed by a 2-week safety follow-up period where researchers will monitor participants for any side effects or health changes after stopping the study medication. Throughout the study, participants will undergo assessments including blood tests to measure changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 24. Other evaluations will monitor safety and health status. The total participation time is approximately 26 weeks, including treatment and follow-up. Researchers will also track adherence to medication and lifestyle instructions during this time.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

This research aims to evaluate the immediate and long-term effects of a structured breathing practice on mental health symptoms including anxiety, depression, perceived stress, and sleep quality among healthcare professionals experiencing burnout. The study focuses on enhancing resilience and mental well-being in clinical care professionals who meet specific burnout criteria. Participants will engage in structured breathing sessions lasting 15, 30, or 36 minutes, tailored to their personal skill levels. The intervention is behavioral and delivered through mobile devices such as smartphones or tablets. The study monitors feasibility, acceptability, and participant satisfaction with the breathing practice over a 4-month period. During the study, healthcare professionals will be assessed for recruitment and retention rates, engagement with the mobile app, and the perceived feasibility and appropriateness of the intervention. Outcomes include participant satisfaction and measures related to mental health symptoms. The total participation duration spans enrollment through 4 months of follow-up, with continuous monitoring of intervention impact and app usage.

Researchers are evaluating how two different radiation therapy approaches affect quality of life in men with localized prostate cancer that has not spread. The study compares near margin-less adaptive radiation therapy (ART), given in 2 treatments, with standard stereotactic ablative body radiotherapy (SABR), given in 5 treatments. ART uses information during treatment to adjust radiation location and dose, aiming to target disease more precisely and spare healthy tissue, potentially reducing side effects compared to SABR. Participants are assigned to one of two groups: one receiving near margin-less ART in 2 sessions spaced at least 3 days apart, and the other receiving standard SABR in 5 sessions spaced at least 2 days apart. Imaging procedures such as cone beam computed tomography (CBCT), computed tomography (CT), and magnetic resonance imaging (MRI) are used to guide treatments and monitor participants. The study also includes surveys and assessments related to patient experience and side effects. During the study, participants complete questionnaires to assess quality of life changes, with follow-up visits at 1, 3, and 6 months after treatment, then every 6 months for up to 5 years. Researchers monitor patient-reported bowel and urinary symptoms, treatment side effects, financial impact, and erectile function, as well as physician-reported toxicities and cancer progression. These measures help evaluate the benefits and risks of the two radiation therapy approaches over time.

Researchers are studying the effects of intravenous ascorbic acid combined with chemotherapy in patients with lymphoma that has returned or not responded to treatment, clonal cytopenia of undetermined significance (CCUS), and chronic myelomonocytic leukemia (CMML). This phase II trial aims to evaluate whether adding ascorbic acid makes cancer cells more sensitive to chemotherapy, potentially improving treatment response rates. The trial includes several groups, with some arms closed to enrollment, focusing on different lymphoma types and blood disorders. Participants receive different treatments depending on their assigned group. Some receive ascorbic acid intravenously along with chemotherapy drugs such as rituximab, ifosfamide, carboplatin, etoposide, cisplatin, cytarabine, dexamethasone, gemcitabine, or oxaliplatin, following specific schedules repeated every 21 or 28 days for several cycles. Other groups receive placebo infusions or high dose ascorbic acid alone or combined with decitabine. Treatments may continue as long as clinically appropriate, with some patients eligible for stem cell transplantation. Throughout the study, participants undergo various assessments including blood tests, bone marrow biopsies, imaging scans like PET/CT or MRI, and heart function tests. Some have central venous catheters placed for treatment delivery. Researchers monitor treatment responses, side effects, survival outcomes, and collect samples for additional research. After treatment, patients are followed every 3 to 6 months for up to 2 years to track long-term outcomes and safety.

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

Researchers are evaluating and comparing the effectiveness and safety of two antibiotics, Azithromycin and Doxycycline, in adults hospitalized with community-acquired pneumonia (CAP) who are also treated with beta-lactam antibiotics. The study focuses on adult patients admitted to the hospital with CAP to determine which antibiotic combination may be more beneficial. This is a Phase 4 study conducted in a hospital setting. Participants will receive either Azithromycin or Doxycycline along with beta-lactam therapy, administered either orally or intravenously. Treatment will begin within 12 hours of hospital admission and continue for 5 to 7 days. The study compares these two treatment approaches directly to assess differences in patient outcomes. During the study, researchers will monitor hospital-free days over a 28-day period as the primary outcome measure. Participants will be assessed for safety and effectiveness of the treatments while hospitalized. The study involves careful observation of treatment duration, timing of administration, and patient recovery progress within the first month after hospital admission.