Zamora

Researchers are evaluating the safety and effectiveness of brenipatide alongside standard care compared to a placebo plus standard care in adult participants with major depressive disorder. This study aims to see if brenipatide can delay the return of major depressive symptoms. It is a Phase 3, randomized, double-blind trial sponsored by Eli Lilly and Company. Participants receive brenipatide or placebo through subcutaneous injections combined with their regular treatment. The study includes three periods a screening period lasting about 1 month, a treatment period of at least 12 months, and a follow-up period of about 2 months. The study duration may be shortened if depressive symptoms worsen or if participants withdraw. During the trial, participants will attend regular visits where various assessments will be conducted, including depression rating scales, functional impairment scores, and quality of life questionnaires. Researchers will monitor body weight changes, anxiety levels, and blood samples to measure drug levels and immune responses. The primary outcome is the time until relapse of major depressive disorder symptoms. Safety and adherence to self-injection and study procedures will be closely followed throughout participation.

This trial studies adults aged 55 to 90 who have psychosis linked to Alzheimers Disease. It is a Phase 3, 38-week, randomized, double-blind, placebo-controlled outpatient study. Its main goal is to assess how well KarXT capsules prevent relapse of psychosis compared to placebo. Additional goals include evaluating time to treatment discontinuation or relapse, and monitoring safety and tolerability. Participants receive either KarXT capsules at various doses or placebo capsules. The study involves a randomized assignment and is conducted under quadruple masking. The treatment period lasts 38 weeks during which KarXT or placebo is taken three times daily. Assessments continue up to approximately 42 weeks to monitor adverse events and other safety measures. Throughout the study, participants attend outpatient visits for evaluations including cognitive tests, assessments of psychosis severity, caregiver reports, lab tests, vital signs, and safety monitoring. Researchers measure relapse timing, treatment discontinuation, neuropsychiatric symptoms, movement scales, weight, and signs related to heart and urinary health. Safety is closely tracked with various assessments until about week 42.

Researchers are evaluating ITI-1284, a drug being studied for agitation associated with Alzheimers dementia. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, and tolerability of ITI-1284 in patients aged 55 years and older who experience agitation related to Alzheimers disease. The study is sponsored by Intra-Cellular Therapies, Inc. and follows strict clinical criteria for diagnosis and agitation severity. Participants are randomly assigned in equal numbers to receive either ITI-1284 or a placebo. ITI-1284 is given as a rapidly disintegrating tablet taken once daily under the tongue at doses of 10 mg or 20 mg. The study consists of three periods a screening period lasting up to 4 weeks to assess eligibility, a 12-week double-blind treatment period where the assigned study drug is taken daily, and a 30-day safety follow-up period after the last dose to monitor any effects. During the study, participants will have assessments including the Cohen-Mansfield Agitation Inventory CMAI to measure agitation levels at Week 12. Other evaluations include the Clinical Global Impression-Severity CGI-S score and cognitive testing with the Mini-Mental State Examination. Safety monitoring occurs throughout the treatment and follow-up periods. Overall, participation lasts approximately 16 to 17 weeks, covering screening, treatment, and safety checks.

Researchers are evaluating ITI-1284, a study drug, for treating psychosis in patients with Alzheimers disease. This multicenter, randomized, double-blind study compares ITI-1284 with a placebo to assess its efficacy, safety, and tolerability in this population. The study includes patients diagnosed with Alzheimers disease and associated psychosis, focusing on improving psychosis symptoms as measured by specific scales. Participants will be randomly assigned to receive either ITI-1284 or a placebo during a 6-week double-blind treatment period. ITI-1284 is given as a 10 mg or 20 mg tablet taken once daily under the tongue. Before treatment, there is a screening period lasting up to 4 weeks to determine eligibility. After treatment, a safety follow-up visit occurs approximately 30 days later to monitor any effects. During the study, participants will undergo various assessments including psychosis rating scales BEHAVE-AD psychosis subscale and CGI-S score at baseline and Week 6. Researchers will monitor safety, tolerability, and adherence throughout treatment and follow-up. The total participation time includes screening, treatment, and the 30-day safety follow-up period, allowing detailed evaluation of the study drugs impact and participant well-being.

Researchers are evaluating ACP-204, a drug targeting serotonin receptor subtype 2A, in adults aged 55 to 95 years with psychosis related to Alzheimers disease. This master protocol includes three independent, randomized, double-blind, placebo-controlled studies aimed at assessing the drugs efficacy and dose response. Substudy 1 is a Phase 2 trial comparing two doses of ACP-204 30 mg and 60 mg to placebo, followed by two Phase 3 confirmatory studies Substudies 2A and 2B that will independently evaluate the doses or a selected dose against placebo. Participants will undergo a screening period lasting up to 49 days before starting a six-week double-blind treatment phase where they will receive daily doses of ACP-204 or placebo, taken once a day at about the same time with or without food. After treatment, there is a 30-day safety follow-up for those not entering an open-label extension, and vital status follow-up for those who end the study early. Each substudy is analyzed separately to assess the drugs impact. During the trial, participants are closely monitored with assessments including the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions SAPS-HD from baseline to week 6. Other evaluations include clinical global impression scales and safety monitoring. Participants must have a study partner or caregiver to assist with visits and adherence. The study is designed to track changes in psychosis symptoms and overall safety through the treatment and follow-up periods.

Researchers are evaluating the use of two different doses of indocyanine green ICG in near-infrared fluorescent cholangiography during laparoscopic cholecystectomy LC, a common surgery to treat symptomatic gallstones. This phase IV randomized trial aims to compare the effectiveness of a standard 2.5 mg dose given over 3 hours before surgery with a reduced 0.25 mg dose given 15 to 30 minutes prior. The goal is to improve visualization of bile ducts and reduce complications like bile duct injury. Participants will be randomly assigned to one of two groups receiving ICG intravenously either 2.5 mg at least 3 hours before surgery or 0.25 mg 15 to 30 minutes before surgery. During surgery, surgeons will assess how well the bile ducts and liver structures can be seen using fluorescence. The study also considers factors like body mass index, type of biliary disease, surgery difficulty, and imaging system used. Fluorescence will be measured both by the surgical teams observations and with digital analysis software. Throughout the study, participants will undergo laparoscopic cholecystectomy with ICG fluorescence cholangiography monitored during surgery. Researchers will measure identification rates of biliary structures before and after dissection, the helpfulness of fluorescence imaging, liver background fluorescence interference, and correlate subjective observations with objective imaging data. The study follows participants for 30 days after surgery to track complications, mortality, operative time, and hospital stay. The total study duration is 13 months, including recruitment and follow-up.

Researchers are examining the use of dexamethasone in adults with acute hypoxemic respiratory failure AHRF, including acute respiratory distress syndrome ARDS, caused by infections such as COVID-19. This condition leads to severe lung inflammation requiring mechanical ventilation and has high mortality rates. The effectiveness of corticosteroids like dexamethasone in treating AHRF and ARDS remains uncertain, prompting this study to compare different dosing strategies to better understand their impact on patient outcomes. The trial is a randomized, controlled, open-label study conducted across multiple centers in Spain. Participants who are mechanically ventilated with confirmed infection-related AHRF will be assigned to receive either a low dose of dexamethasone 6 mg daily for 10 days or a higher dose 20 mg daily for 5 days, followed by 10 mg daily for 5 days. The study compares these two dosing regimens to determine which may better reduce mortality and improve ventilator-free days. During the trial, participants will be closely monitored in intensive care units, with primary outcomes measured by mortality at 60 days and secondary outcomes by the number of days free from mechanical ventilation within 28 days. Researchers will gather data on lung function, infection status, and overall health. Participants progress will be followed to assess the safety and effects of the dexamethasone doses over the study period.

Researchers are studying how well women with postmenopausal osteoporosis follow their prescribed treatment plans involving oral bisphosphonates combined with calcium and vitamin D supplements. This observational, cross-sectional study seeks to understand patients adherence to these common treatments and factors influencing their satisfaction and persistence with the therapy. The study involves a single visit aligned with a patients routine follow-up care. During this visit, researchers will review medical history and conduct interviews using three questionnaires to assess how often patients take their medications, any forgetfulness, and their satisfaction with the current treatment regimen. Participants will provide information about their treatment habits and experience in this one-time visit. The main focus is measuring intergroup adherence, persistence, and satisfaction, along with identifying reasons for non-adherence or non-persistence. This approach helps researchers understand real-world treatment patterns without altering regular clinical care.

Inflammatory bowel disease IBD, including ulcerative colitis UC and Crohns disease CD, involves chronic inflammation affecting the digestive tract with periods of flare-ups. This study evaluates the real-world effectiveness and safety of granulocytapheresis GMA using the Adacolumn device in adult patients with UC or CD. GMA selectively removes inflammatory cells from the blood to reduce inflammation and is considered as an alternative or complementary treatment to corticosteroids and biological therapies in IBD management. Participants will receive GMA treatment with Adacolumn, typically following the standard regimen of one session per week for five weeks. In some cases, induction regimens with two sessions per week or maintenance regimens with one to two sessions per month may be used. The study is noninterventional and conducted across about 30 sites, aiming to enroll approximately 350 patients. Treatment use and regimens will be observed according to routine clinical practice without interfering with patient care. Patients will be followed through up to four visits baseline, and follow-ups at about 1 month, 6 months, and 12 months after the last induction session. Data collection includes clinical remission rates, steroid use, adverse events, quality of life assessments, and biomarker changes. All assessments coincide with routine care visits. The primary outcome is the proportion of patients achieving steroid-free remission at six months, with additional secondary outcomes evaluating remission rates, treatment regimens, safety, and quality of life over 12 months.

Researchers are conducting a national, multicenter observational study called SOGUG-PRINCIS to collect and analyze data on patients with genitourinary cancers treated with recently approved drugs under routine clinical practice in Spain. This study is both retrospective and prospective, aiming to validate real-world effectiveness of these drugs and support future funding decisions. It will serve as a registry where new subprojects will open whenever new drugs receive authorization. The study follows patients who have started treatment with specific drugs funded by the Spanish National Health System, including darolutamide combined with androgen deprivation therapy and docetaxel for hormone-sensitive prostate cancer, adjuvant nivolumab after surgery for urothelial carcinoma, and enfortumab vedotin for urothelial carcinoma. All treatments follow their approved dosing and administration guidelines and standard clinical practice. Participants progress will be monitored through routine data collection to evaluate outcomes such as progression-free survival at 18 months, relapse-free survival at 24 months, and overall survival at 12 months after starting treatment. Data will be gathered from patients treated at participating centers, with follow-up continuing as per routine care. The study does not intervene in treatment decisions, which are made independently before enrollment.