Provo

Researchers are evaluating azetukalner as a treatment for adults diagnosed with moderate-to-severe Major Depressive Disorder MDD. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the clinical efficacy, safety, and tolerability of azetukalner when taken alone. The study involves participants aged 18 to 74 who have experienced their first major depressive episode before age 50. Participants receive either azetukalner 20 mg or a placebo orally once a day with food, preferably with the evening meal, for a total of 6 weeks. The study includes two groups one taking azetukalner and the other taking placebo, both under blinded conditions to ensure unbiased results. During the study, participants will be regularly monitored through clinical evaluations, including changes in depression severity scores such as the Hamilton Depression Rating Scale HAMD-17 and other scales measuring pleasure and clinical global impression. Safety and tolerability will be observed from screening through 8 weeks after the final dose. The total study duration includes screening, 6 weeks of treatment, and post-treatment safety follow-up.

Researchers are evaluating the immune response and safety of an investigational combined measles, mumps, rubella, and varicella vaccine MMRVNS compared to the already licensed MMRV vaccine ProQuad. The study focuses on healthy children aged 15 months to 6 years who have previously received a first dose of any measles, mumps, rubella, and varicella-containing vaccine. This Phase 3a, randomized, observer-blind trial aims to assess prevention by comparing these two vaccines when given as a second dose intramuscularly. Participants receive a single intramuscular dose of either the investigational MMRVNS vaccine or the licensed MMRV vaccine on Day 1. The study uses a parallel design with two groups one receiving MMRVNS and the other receiving MMRV. The vaccines are administered as a second dose to children previously vaccinated according to their countrys immunization schedule. The study monitors participants closely for immune response and safety after vaccination. Throughout the study, children undergo assessments including blood tests to measure Immunoglobulin G IgG responses against measles, mumps, rubella, and varicella at Day 43. Safety evaluations include monitoring for injection site reactions, systemic events, and adverse events up to 181 days after vaccination. The study tracks solicited and unsolicited adverse events and serious adverse events to understand the safety profile. Participation lasts until study completion, with multiple follow-up periods to ensure thorough monitoring.

Researchers are studying the long-term safety and tolerability of KarXT and KarX-EC in adolescents with schizophrenia and children and adolescents with autism-related irritability. This Phase 3, open-label study evaluates these treatments to better understand their effects over extended periods in these young populations. The trial is led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company. Participants receive KarXT as the study drug, with dosing specified on certain days. The study includes two groups adolescents aged 13 to 17 years with schizophrenia receiving KarXT alone, and children and adolescents aged 5 to 17 years with irritability associated with autism spectrum disorder receiving KarXT combined with KarX-EC. The treatment period extends up to 54 weeks, during which safety and tolerability are closely monitored. During the study, participants are regularly evaluated for treatment-emergent adverse events, serious adverse events, and adverse events of special interest. Additional assessments include monitoring for procholinergic and anticholinergic symptoms, suicidal ideation and behavior, and movement disorders using validated rating scales. The total participation duration spans up to 54 weeks, encompassing treatment and observation to track long-term effects and safety outcomes.

Researchers are studying the effects of a drug called TNX-102 SL on adults with moderate to severe major depressive disorder MDD. This clinical trial aims to find out if TNX-102 SL improves depression symptoms compared to a placebo and to assess its safety. The study focuses on changes in depression symptoms measured by a rating scale over six weeks. Participants will take either 5.6 mg of TNX-102 SL two 2.8 mg tablets or placebo tablets every night at bedtime for six weeks. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the drug or placebo. Checkups and tests will take place at the clinic every two weeks during the treatment period. During the trial, participants will have depression symptom assessments and other evaluations to monitor safety and treatment effects. The main measurement is the change in depression rating scores from the start to week six. Participants will be closely followed throughout the six-week treatment, with regular visits every two weeks for monitoring and questionnaires.

Researchers are evaluating the safety and immune response of a new multivalent pneumococcal vaccine called PG4 compared to the currently used 20-valent pneumococcal conjugate vaccine 20vPnC in healthy infants. The study aims to understand how well the new vaccine helps fight germs causing pneumonia, meningitis, and ear infections. This phase 3 trial involves infants aged 2 to 6 months and seeks to determine if the new vaccine is as safe as the existing one while assessing its immune response when given alongside other childhood vaccines. Participants are divided into three groups based on age and location. Group 1 includes about 3000 infants aged 2 months who receive either PG4 or 20vPnC by injection into the left thigh muscle at ages 2, 4, 6, and 12 to 15 months. Groups 2 and 3, with about 230 infants outside the United States aged 2 to 6 months, receive vaccinations on a slightly different schedule, with Group 3 exploring both intramuscular and subcutaneous administration of PG4. Participants have a randomized chance of receiving one of the study vaccines. During the study, infants will attend six clinic visits and one phone call where parents report any side effects. Blood samples will be collected three times to assess the immune response by measuring proteins that fight the germs. Researchers will track local and systemic reactions, adverse events, and serious adverse events throughout the study period, which lasts about 1 to 1.5 years depending on the group. The study monitors safety closely to compare the new vaccines effects with the current standard vaccine.

Researchers are evaluating a new brain stimulation treatment called accelerated transcranial magnetic stimulation TMS for adults aged 18 to 65 with post-traumatic stress disorder PTSD. PTSD causes symptoms like flashbacks, avoidance, mood changes, and heightened alertness after trauma. This pilot study focuses on using brain scans to guide personalized TMS targeting the brain areas involved in fear and control to improve symptoms. The study aims to assess if this fast-paced treatment is practical, safe, and shows early signs of reducing PTSD symptoms. Participants first undergo a brain scan fMRI to map connections between their right amygdala fear center and right dorsolateral prefrontal cortex control area. Using this map, they receive accelerated continuous theta burst stimulation cTBS to the identified brain target. Treatment lasts 5 consecutive days with 10 short sessions each day, totaling 90,000 magnetic pulses. The procedure uses a neuronavigation system for precise coil placement and is monitored continuously for safety. During the study, participants have a screening and baseline phase, followed by the 5-day treatment and then a 3-month follow-up period. Researchers assess PTSD symptoms using questionnaires and interviews at baseline, after treatment, and at 1 and 3 months. Repeat brain scans evaluate changes in brain connectivity. Safety is closely monitored throughout, including side effects like headaches. Total participation lasts about 3.5 months.

Researchers are evaluating the adaptation and implementation of an innovative clinical decision support CDS tool called ePNa, originally validated in emergency departments, for use in urgent care clinics to improve pneumonia diagnosis and treatment. This study aims to combine ePNa with Stanfords CheXED artificial intelligence model to classify chest images quickly and accurately. The goal is to enhance pneumonia care in ambulatory settings where high patient volumes may benefit from updated and efficient diagnostic tools, especially as COVID-19 evolves. The study involves adapting ePNa for use in urgent care clinics by modifying it to work with the more limited patient data available in these settings and incorporating a chest imaging prompt. The combined ePNa-CheXED tool will be piloted among super user clinicians during clinic shifts. One of two clusters of urgent care clinics will receive the adapted tool, while the other will serve as usual care control. Additionally, a physician survey will assess clinicians experiences with ePNa-CheXED six months after implementation. Participants will be patients aged 12 and older diagnosed with pneumonia, confirmed by radiographic imaging. Physicians and advanced practice clinicians in selected urgent care clinics will also participate by completing surveys. The study will monitor outcomes including the accuracy of pneumonia diagnosis, changes in transfer rates to emergency departments, unplanned subsequent ED visits or hospitalizations, and overall healthcare resource use. The study will continue for up to three years, with ongoing evaluation of ePNa use and impact in the urgent care clinical environment.

Researchers are evaluating a method of cervical ripening using a Foley catheter for women who are having their first baby and are scheduled for labor induction at term 37 weeks or more. The study compares outpatient cervical ripening with a Foley catheter to the usual inpatient cervical ripening methods. The aim is to see if outpatient use of the Foley catheter reduces the rate of Cesarean delivery and lowers risks for mothers and newborns compared to inpatient care. Participants will be randomly assigned to one of two groups one group will begin cervical ripening with a Foley balloon catheter at home outpatient, while the other group will start cervical ripening in the hospital using either a Foley balloon or another cervical ripening method. The trial focuses on comparing these approaches to find the best care process for labor induction. During the study, researchers will monitor Cesarean delivery rates at delivery as the primary outcome. They will also assess maternal and neonatal health up to 6 weeks after delivery, including maternal satisfaction, perceived control during birth, length of hospital stay, and neonatal intensive care admissions. Participants will be followed closely with various assessments and questionnaires to measure these outcomes and ensure safety throughout the postpartum period.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

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.