Zamora

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Researchers are evaluating the safety and effectiveness of KarXT in preventing relapse of psychosis symptoms in people aged 55 to 90 years who have psychosis associated with Alzheimer's Disease. This Phase 3 study is randomized, double-blind, placebo-controlled, and conducted at multiple outpatient centers. The main goal is to compare relapse prevention between KarXT treatment and placebo over 38 weeks, while also assessing time to discontinuation, safety, and tolerability. Participants receive either KarXT in varying doses (ranging from 20 mg/2 mg to 66.7 mg/6.67 mg taken three times daily) or placebo capsules. The study lasts 38 weeks, during which participants remain on assigned treatment in an outpatient setting. The randomized, double-blind design ensures neither participants nor researchers know who receives KarXT or placebo during the study. Throughout the study, participants will visit the clinic regularly for assessments of their psychosis symptoms, safety checks, and overall health. Researchers will track the time to relapse of psychosis symptoms as the primary outcome. They will also monitor safety and tolerability through clinical examinations and other evaluations. The total duration of participation is 38 weeks from randomization to the end of the study period.

Researchers are evaluating the effectiveness, safety, and tolerability of ITI-1284 for people with agitation linked to Alzheimer's dementia. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to compare ITI-1284 to a placebo in patients aged 55 years and older who meet specific criteria for Alzheimer's disease and agitation. Participants will be involved in three main periods: a screening phase of up to 4 weeks to confirm eligibility; a 12-week double-blind treatment phase where patients will be randomly assigned to receive either ITI-1284 (10 mg or 20 mg) or a placebo, both given once daily as a rapidly disintegrating tablet under the tongue; and a 30-day safety follow-up period after the last dose to monitor any safety concerns. During the study, participants will undergo various assessments including agitation severity measured by the Cohen-Mansfield Agitation Inventory at Week 12. Other evaluations include cognitive testing, clinical global impressions, and monitoring for side effects. Researchers will track adherence and safety through visits and questionnaires over the total study duration, which includes screening, treatment, and follow-up.

Researchers are evaluating the effectiveness, safety, and tolerability of ITI-1284 compared to a placebo in treating psychosis associated with Alzheimer's disease. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study focuses on patients aged 55 and older who meet specific clinical criteria for Alzheimer's disease and psychosis. The study aims to assess changes in psychosis symptoms using the BEHAVE-AD psychosis subscale score after 6 weeks of treatment. Participants will be randomly assigned in equal numbers to receive either ITI-1284 or a placebo. ITI-1284 is administered as a rapidly disintegrating tablet taken once daily under the tongue at doses of 10 mg or 20 mg. The study includes three periods: up to 4 weeks of screening to determine eligibility, a 6-week double-blind treatment phase where participants receive their assigned medication, and a 30-day safety follow-up after the last dose to monitor any adverse effects. During the study, participants will undergo assessments to confirm Alzheimer's disease diagnosis and psychosis presence, including biomarker tests, clinical rating scales, and cognitive evaluations. Caregivers will be involved as designated support persons. Researchers will monitor symptom changes, safety, and tolerability throughout the treatment and follow-up periods. The primary outcome is the psychosis subscale score measured at week 6, with safety follow-up visits approximately 30 days after treatment ends.

Researchers are evaluating ACP-204, a drug that blocks a specific serotonin receptor, in adults aged 55 to 95 with Alzheimer's Disease Psychosis (ADP). The study is designed as a master protocol with three independent, multicenter, randomized, double-blind, placebo-controlled trials. The trials include Phase 2 and Phase 3 studies to assess the drug's effectiveness and safety in treating psychotic symptoms associated with ADP. The research involves three substudies. Substudy 1 (Phase 2) tests two doses of ACP-204, 30 mg and 60 mg, against a placebo to evaluate dose response. Substudies 2A and 2B (both Phase 3) will independently confirm the effects of either both doses or a single dose from Part 1 compared to placebo. Each substudy includes a screening period of up to 49 days, a six-week double-blind treatment phase, and a 30-day safety follow-up for those not continuing into an open-label extension. Vital status follow-up is conducted for participants who end the study early. Participants will receive regular assessments, including evaluations of psychotic symptoms using the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales from baseline to Week 6. Other study involvement includes brain imaging scans and biomarker tests to confirm Alzheimer's disease diagnosis, cognitive testing, and monitoring of safety and vital status throughout the study periods. Stable living arrangements and support from a caregiver are required to complete all study visits.

Researchers are evaluating the use of two different doses of indocyanine green (ICG) in near-infrared fluorescent cholangiography during laparoscopic cholecystectomy, a common surgical treatment for symptomatic gallbladder disease. This phase IV, multicenter, randomized open-label trial aims to improve visualization of bile ducts to reduce the risk of bile duct injury, a serious complication associated with this surgery. The study will also examine factors such as body mass index, type of biliary disease, and surgical difficulty that could influence outcomes. Participants will be randomly assigned to receive either a standard dose of 2.5 mg ICG at least three hours before surgery or a reduced dose of 0.25 mg administered 15 to 30 minutes prior. The ICG is given intravenously through a peripheral vein in the upper limb. Surgeons will assess the biliary structures during surgery using fluorescence imaging, and specialized software will analyze the images to measure bile duct-to-liver fluorescence ratios. This design allows comparison of the diagnostic quality and interference from liver fluorescence between the two dosing strategies. Participants will be followed for one month after surgery during which researchers will monitor identification rates of biliary structures before and after dissection, the usefulness of fluorescence cholangiography, and any complications. The study will also track operative time, hospital stay length, and mortality within 30 days. Data collection includes subjective surgeon evaluations and objective digital image analysis to support findings. The trial plans to enroll 122 adults aged 18 years or older undergoing elective, early, or urgent deferred laparoscopic cholecystectomy.

Researchers are investigating the effects of different doses of dexamethasone, a corticosteroid, in adults with acute hypoxemic respiratory failure (AHRF) caused by infections, including COVID-19. This condition ranges from mild respiratory illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The trial aims to clarify whether moderate doses of dexamethasone reduce mortality more than low doses in patients requiring mechanical ventilation in intensive care units. Participants will be randomly assigned to receive intravenous dexamethasone either at a low dose of 6 mg per day for 10 days or a higher dose regimen of 20 mg per day for 5 days followed by 10 mg per day for another 5 days. This is a randomized, controlled, open-label study conducted across multiple centers in Spain. The study focuses on patients who are mechanically ventilated with confirmed pulmonary or systemic infections causing AHRF or ARDS. During the study, researchers will monitor patients for 60-day mortality as the main outcome and assess the number of days they are free from mechanical ventilation within 28 days. The study follows the intention-to-treat principle, ensuring all randomized patients are analyzed according to their assigned treatment. The trial includes detailed clinical assessments, chest imaging, and oxygenation measurements as part of patient evaluation throughout the treatment period.

Researchers are evaluating how well women with postmenopausal osteoporosis stick to their combined treatment of oral bisphosphonates along with daily calcium and vitamin D supplements. This is an observational, cross-sectional, and multicenter study focused on understanding patient adherence to these common therapies for managing osteoporosis after menopause. The study involves collecting information during a single visit aligned with the patient's usual follow-up care. During this one-time visit, data will be gathered from the patient's medical history and through an interview using three questionnaires. These questionnaires assess how the patient takes their treatment, including frequency, any forgetfulness, and satisfaction with their current treatment plan. The treatment regimens under study involve bisphosphonates taken orally on a weekly or monthly basis, combined with daily calcium and vitamin D supplements in sachet or chewable tablet form. Participants will provide information about their medication habits during the visit, which coincides with routine clinical care. Researchers will measure adherence to the combined treatment as the primary outcome. Since the study involves only a single visit, it minimizes participant burden while providing insight into real-world treatment adherence in women with postmenopausal osteoporosis.

Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), involves chronic inflammation in different parts of the digestive tract, causing relapsing symptoms. The inflammatory process features increased activated granulocytes and monocyte-macrophages, which contribute to tissue damage. Granulocytapheresis (GMA) is being studied as a treatment alternative, especially for patients dependent on corticosteroids, to reduce inflammation by selectively removing these inflammatory cells from the blood. The study evaluates the use of the Adacolumn4 medical device for GMA therapy in adults diagnosed with UC or CD under real-world conditions. Patients will receive GMA sessions typically once a week for five weeks, with some receiving more frequent or maintenance sessions depending on their condition. The treatment aims to decrease the need for steroids and may be combined with other therapies. The study includes up to four visits: baseline, 1 month, 6 months, and 12 months after the final induction session. Participants will be monitored through routine clinical visits without extra interventions beyond usual care. Data collected include clinical remission rates without steroids six months after GMA therapy, safety information, changes in treatment, and quality of life measures. The total follow-up after treatment completion is approximately 12 months, ensuring careful observation of treatment effects and patient well-being.

Researchers are conducting an observational study called SOGUG-PRINCIS to collect and analyze data on the effectiveness of drugs recently approved for treating genitourinary tumors under routine clinical practice in Spain. This national, multicenter study includes both retrospective patient data and prospective follow-up, aiming to validate real-world outcomes compared to those reported in phase III clinical trials. The study covers cancers originating in the kidney, ureter, bladder, prostate, testicle, urethra, penis, and seminal vesicles. The study observes patients treated with drugs such as darolutamide combined with androgen deprivation therapy and docetaxel, adjuvant nivolumab after surgical removal of urothelial carcinoma, and enfortumab vedotin. All treatments follow their approved dosing and administration guidelines in standard clinical practice. New subprojects may be added as new drugs gain funding approval by the Spanish National Health System, with each subproject focusing on specific primary endpoints. Participants' involvement includes treatment decisions made independently from the study, with data collected afterward to assess outcomes. Researchers will track progression-free survival at 18 months, relapse-free survival at 24 months, and overall survival at 12 months after treatment initiation. The study also serves as a registry for genitourinary cancer treatments funded nationally, supporting long-term evaluation of drug effectiveness in real-world settings.