Santiago De Queretaro

Researchers are evaluating the effectiveness of furosemide alone compared to furosemide combined with albumin in critically ill adults with fluid overload. The study aims to see if adding albumin improves urine output and kidney function compared to standard furosemide treatment. Primary outcomes focus on urine output two hours after treatment, along with changes in kidney blood flow markers and biochemical measures. Secondary outcomes include blood pressure, electrolyte levels, and kidney resistance. Participants will receive either furosemide alone or furosemide plus 50 grams of 25% albumin intravenously, each infused over 30 minutes. The albumin is given together with furosemide in the combined treatment group, while the other group receives a placebo saline infusion with furosemide. The treatments are standardized and given as a single dose. Throughout the study, researchers will measure urine output two hours after treatment and monitor blood and urine tests to assess kidney function and electrolyte balance. Bedside ultrasound will check fluid overload and kidney blood flow, and vital signs like blood pressure will be tracked. The goal is to understand if albumin enhances the effects of furosemide in improving urine output and kidney health in critically ill patients. Participation is during the ICU stay when diuretics are started for fluid overload.

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

Researchers are evaluating the safety and effectiveness of levosulpiride to improve retinal changes caused by diabetic macular edema (DME) and diabetic retinopathy (DR), which are leading causes of vision loss in adults with diabetes. This randomized, double-blind, placebo-controlled phase 2 trial explores a new treatment approach by raising prolactin hormone levels using levosulpiride, a dopamine D2 receptor blocker. The study aims to find better options beyond current therapies like laser treatment and anti-angiogenic injections, which have limitations and risks. Participants with different stages of DR and DME receive either levosulpiride or a placebo pill taken three times daily alongside their standard diabetes and blood pressure treatments. Those with proliferative DR who require vitrectomy surgery take the study medication for one week before their procedure. Patients with DME receiving anti-angiogenic therapy with ranibizumab take the study medication for 24 weeks. The trial carefully monitors changes in retinal thickness, eye health signs through imaging after pupil dilation, and levels of prolactin and vasoinhibin in blood and eye fluid samples. During the study, participants undergo detailed eye exams, including optical coherence tomography and fundus imaging, as well as blood tests and, if applicable, vitreous fluid sampling during vitrectomy. Researchers track visual acuity and various retinal features to measure treatment effects. The study includes careful data collection, quality checks, and safety monitoring over the treatment periods, ensuring complete and accurate information to evaluate levosulpiride's role in managing diabetic retinal disease.

Alcohol Use Disorder (AUD) affects many aspects of a person's life including physical health, social relationships, and mental well-being. This research aims to study how high-frequency repetitive transcranial magnetic stimulation (rTMS) might help improve executive functions, such as cognitive flexibility, in people who have stopped drinking alcohol. Executive dysfunctions in AUD are linked to persistent negative behaviors and relapse risk, making it important to find new treatments to support recovery. Participants in this study will receive either active or sham rTMS using a Magstim Rapid 2 stimulator. Those receiving active treatment will have 10 Hz stimulation applied to the left dorsolateral prefrontal cortex (DLPFC) at 100% motor threshold with 1500 pulses per session delivered in two daily sessions, four days a week, over four weeks. The sham group will receive similar sessions with the coil placed on a different area to simulate the procedure without actual stimulation. Throughout the study, participants will undergo neuropsychological tests and brain imaging to assess changes in cognitive abilities and brain structure. Primary outcomes include changes in executive functions measured by tasks such as the Wisconsin Card Sorting Task and Stroop effect from baseline to 4 weeks. Clinical and cognitive effects will also be monitored for six months after treatment to evaluate lasting benefits and safety.

This research focuses on patients with high-risk Proliferative Diabetic Retinopathy (PDR) who require surgery due to complications from diabetes. The study aims to evaluate the effects of giving an injection of bevacizumab, a medication, immediately after vitrectomy surgery. Participants have type I or II diabetes and active PDR in the eye needing surgery, with vision ranging from 20/40 to hand motions. Participants will be randomly assigned to either receive an injection of bevacizumab right after their vitrectomy surgery or not receive this injection. The surgery, called pars plana vitrectomy, is performed to address issues like non-clearing vitreous hemorrhage, tractional retinal detachment, or fibrous proliferation affecting vision. Only one eye per participant will be included in the study. During the study, participants will be followed for six months to monitor outcomes. Researchers will assess visual acuity and other eye health measures to determine the effects of the treatment. Participants must be able to commit to the six-month follow-up period. The study excludes patients with other significant eye diseases, previous vitrectomy in the study eye, uncontrolled neovascular glaucoma, or uncontrolled hypertension despite treatment.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.

Researchers are evaluating the long-term safety of nivolumab monotherapy, including its use with combinations and other cancer treatments, in patients with various types of cancer. This Phase 2 study focuses on patients who have previously participated in Bristol-Myers Squibb (BMS) sponsored trials involving nivolumab and other cancer therapies. The goal is to gather information on safety over an extended period following treatment. Participants may receive nivolumab alone or alongside other cancer drugs such as ipilimumab, cabozantinib, trametinib, relatlimab, capecitabine, bevacizumab, and others. Each drug is given at specified doses on designated days according to the study protocol. Treatment continuation or rechallenge is based on the participant's status from their prior parent study, including treatment holds after lasting responses or eligibility for restarting treatment. During the study, participants will be closely monitored for adverse events, including general, drug-related, serious, immune-mediated, and select adverse effects, as well as any deaths, from the start of treatment until 135 days after stopping treatment. Safety assessments and clinical evaluations will be conducted regularly to track these outcomes and ensure participant well-being throughout the trial.

Researchers are evaluating a new topical medication called MW-III to treat thermal burns. This phase 2 pilot study compares MW-III to Silvadene4 Cream 1% (Silver Sulfadiazine) by measuring how long it takes for partial thickness burns to heal, defined as 95% or more re-epithelialization. The study focuses on adults with burns involving a limited body surface area. Participants will receive either MW-III or Silvadene4 Cream applied topically twice a day to their burns. The treatment period lasts 28 days, during which the healing progress of the partial thickness target burn is closely monitored. The study aims to assess both the safety and effectiveness of MW-III compared to the standard treatment. During the study, participants will be regularly evaluated for wound healing progress, safety, and any adverse effects. The main measurement is the time it takes for the treated burn to achieve 95% skin regrowth. Participants must be able and willing to give informed consent and follow study procedures. The total duration of involvement is at least 28 days of treatment monitoring.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.