This Phase III trial aims to investigate the efficacy and safety of survodutide (BI 456906) once weekly versus placebo on defined as resolution of steatohepatitis, reduction of liver fibrosis in liver biopsy and long-term improvement in clinical liver outcomes observed in trial participants with MASH and fibrosis stage F2-F3.

This study is for patients who have been diagnosed with low grade, intermediate risk non-muscle invasive bladder cancer. It is testing an investigational drug called TYRA-300. "Investigational" means that the drug has not been approved by the United States Food and Drug Administration (FDA).

The purpose of the study is to see whether TYRA-300 can shrink or eliminate bladder tumors without surgery. Normally, standard care involves a surgery called transurethral resection of bladder tumor (TURBT), but in this study at least one tumor will remain in place to see if the study drug works. The study will also evaluate the genetics of the cancer to see if certain mutations or changes in proteins affect how the drug works.

TYRA-300 is taken by mouth once daily. The dose level will be assigned by the study doctor. Participants may be in the study for about 36 months, which includes a screening period (up to 28 days), a study treatment phase (with visits every 4 weeks and more frequent visits during the first 8 weeks), an end-of-treatment visit, a safety follow-up about 28 days later, and long-term follow-up every 12 weeks. There will be a total of 3 patients enrolled locally over the course of 12 months.

This study aims to evaluate the clinical development program for icotrokinra in the treatment of adult participants with moderately to severely active CD. Icotrokinra may offer additional advantages beyond injectable antibody therapies and available
oral therapies for the treatment of patients with moderate to severely active CD due to its oral route of administration, high local exposure to GI tissues, and systemic activity. Overall, the program will evaluate icotrokinra treatment in a target of 1092 participants through at least 52 weeks but participants can participate in a long-term extension for 4 years (total duration approximately 5 years).

Study 812P310 is a multicenter, open-label extension study aimed to assess long-term safety and efficacy of SPN-812 in the treatment of ADHD in pediatric subjects who have participated in a previous blinded study of SPN-812.

All subjects who complete a blinded study of SPN-812 will have the option to participate in the OLE study in which all subjects receive SPN-812 (Study Medication, SM). Starting dose, dose range, and dose adjustments are all based on which double blind study the subject completed and, if applicable, the current age of the subject (Table 1). A subject who completed Study 812P202, 812P301 or 812P303, enters this OLE study at age 11 years, and then turns 12 while still in the study, their upper potential dose limit will then be raised from 400 mg to 600 mg and titration may occur at either 100 or 200 mg/week, as specified for the 12-17 year-old age group.

Feeding requires babies to coordinate sucking and swallowing, which depends on healthy brain development. Some newborns who experience brain injury or serious illness cannot safely practice feeding by mouth, which disrupts the development of these important brain circuits. As a result, many of these infants require a feeding tube placed in the stomach (called a G-tube) when they leave the hospital. Unfortunately, long-term feeding tube dependence is linked to poorer growth, delayed development, and breathing problems. Despite how common and serious these feeding difficulties are, there are currently no effective therapies for infants with the most severe swallowing problems. This study will test a non-invasive therapy called transcutaneous auricular vagus nerve stimulation (taVNS), which gently stimulates a nerve in the ear that connects to the brain. When paired with structured oral motor exercises, this approach may help strengthen the brain circuits needed for feeding. We will study 12 infants with severe feeding impairments to evaluate whether this therapy is safe, feasible, and shows early signs of benefit. This project will provide early evidence about whether a targeted brain-based therapy can improve feeding outcomes during a key window of early development.

This study is being conducted to evaluate the drug AZD0292, including how safe it is, how long it stays in the blood, and if it may help in reducing the number of exacerbations in people with Pseudomonas aeruginosa in their lungs. These patients have more frequent lung exacerbations and reduced quality of life. Pseudomonas aeruginosa is a bacteria that can make the symptoms of bronchiectasis worse. The study drug (AZD0292) works by attaching to Pseudomonas aeruginosa, thereby reducing its effects on the lungs and improving symptoms.
This study aims not only to test AZD0292 but is also being done to better understand bronchiectasis disease and its associated health problems.
Study drug (AZD0292) or placebo, will be given to participants as an intravenous (IV) infusion. The study is double-blinded.
About 435 participants with bronchiectasis 12 years of age and older, weighing at least 35kg will take part in this study. This study will be conducted globally in approximately 25 countries.

Researchers at the Medical University of South Carolina are studying speech and language in people with Parkinson's disease (PD), progressive supranuclear palsy (PSP), and multiple system atrophy (MSA), and in healthy adult volunteers. These conditions can change how a person speaks and uses language, and the changes may differ from one condition to another. The study uses a tablet-based set of short speech and language tasks, called SLANG, together with computer software that measures features of the recorded speech, such as pitch, timing, and word choice. Participants also complete standard speech, language, and thinking tests and a brief exam by a neurologist, which researchers compare against the tablet measurements. The purpose of this study is to gather early research data: to build a database of these measurements across the groups, to check whether the tablet captures them reliably, and to explore whether they differ between conditions. SLANG is not used to diagnose participants or to guide their medical care in this study. The long-term goal of this research is to develop a tool that could someday help clinicians recognize and tell these conditions apart earlier, but testing such a tool for diagnosis is beyond the scope of the current study.