Santiago De Queretaro

This research evaluates how well furosemide alone compares to furosemide combined with albumin in critically ill adults who have fluid overload. The study aims to find out if adding albumin improves urine output and kidney function markers compared to using furosemide by itself. Key measurements include urine output two hours after treatment, kidney blood flow indicators, and various biochemical tests. Participants are randomly assigned to receive either furosemide at 1 mg per kg of body weight intravenously over 30 minutes with a placebo, or the same dose of furosemide together with 50 grams of 25% albumin infused over 30 minutes. The study uses bedside ultrasound to assess fluid overload signs and monitors blood pressure, electrolytes, and kidney filtration rates during the trial. During the study, participants undergo urine output measurement at two hours and blood tests to track changes in kidney function and electrolyte levels up to 24 hours after treatment. Ultrasound evaluations assess vein size and congestion at baseline and after two hours. Researchers monitor safety and response to treatment while collecting data on urine volume and kidney health markers to understand the impact of adding albumin to furosemide therapy.

Researchers are investigating new treatment options for breast cancer that is hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2-, specifically for cases that are unresectable locally advanced or metastatic. This type of breast cancer involves cancer cells that depend on hormones like estrogen or progesterone and have low HER2 protein levels. The study focuses on comparing the effects of patritumab deruxtecan against chemotherapy or trastuzumab deruxtecan in patients whose cancer has progressed despite prior treatments. Participants receive either patritumab deruxtecan through intravenous infusions every three weeks for about 13 months or a treatment chosen by their physician, which may include various chemotherapy drugs or trastuzumab deruxtecan, administered according to specific schedules for up to 13 months. The study is randomized and open-label, meaning participants are randomly assigned to one of the treatment groups, and both the patients and researchers know which treatment is given. Throughout the study, participants undergo regular assessments to monitor cancer progression and overall survival for up to approximately 85 months. Researchers evaluate tumor response, duration of response, and changes in quality of life using standardized questionnaires. Safety is carefully monitored by recording adverse events and treatment discontinuations. The goal is to understand if patritumab deruxtecan can improve outcomes compared to current treatment options.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Researchers are evaluating new diagnostic methods for asthma and chronic obstructive pulmonary disease COPD that can be used in primary care settings. Traditional spirometry relies on patients ability to perform forceful breathing maneuvers, which can be challenging and limit accurate diagnosis. This observational study aims to assess how well oscillometry and fractional exhaled nitric oxide FeNO testing work compared to specialist diagnosis, across six countries in the Middle East, Africa, Asia, and Latin America, to improve early and reliable detection of asthma and COPD. Primary care physicians will be trained to use oscillometry and FeNO testing following international guidelines and will use devices like the Ambulatory Lung Diagnosis System. Patients suspected of having asthma or COPD will be assessed through history, symptom questionnaires, and these tests. If specialist evaluation is not possible on the same day, it will occur within three days. No follow-up visits are planned. The study compares diagnosis accuracy and feasibility between primary care and specialist settings. Participants will provide consent and complete symptom questionnaires, followed by primary care assessments including oscillometry and FeNO testing. Researchers will measure the accuracy of primary care diagnoses against specialist diagnoses using statistical methods and observe agreement, sensitivity, and specificity within one to three days. The study does not require further follow-up, aiming to inform integration of these diagnostic tools into routine primary care for better asthma and COPD identification.

Researchers are evaluating the safety and effectiveness of levosulpiride in improving eye problems caused by diabetic macular edema DME and diabetic retinopathy DR. These conditions are leading causes of vision loss in adults with diabetes, and current treatments like laser therapy or anti-angiogenic drugs have limitations and risks. This study explores a new approach by raising prolactin hormone levels using levosulpiride, aiming to protect the retina and reduce disease progression. Participants with different stages of diabetic eye disease will be randomly assigned to receive either levosulpiride or a placebo pill taken orally three times a day. Some groups include patients undergoing vitrectomy surgery or receiving standard anti-angiogenic treatment with ranibizumab levosulpiride or placebo is given alongside these therapies. Treatment durations vary from one week to 24 weeks depending on the group, always combined with regular diabetes and blood pressure management. During the study, participants will undergo detailed eye exams including imaging tests like optical coherence tomography and fundus photography, blood tests to measure prolactin and other markers, and vision assessments. Researchers will monitor retinal changes, visual acuity, and hormone levels to assess treatment effects. Safety and adherence will be carefully tracked throughout the study period, which extends up to several months. The trial also involves thorough data collection and quality control to ensure reliable results.

Researchers are investigating the effects of high-frequency repetitive transcranial magnetic stimulation rTMS on improving executive functions in adults with Alcohol Use Disorder AUD who are currently abstinent. AUD can cause lasting changes in brain function and behavior, including difficulties with cognitive flexibility, which may contribute to relapse. This study aims to assess both short- and long-term clinical and cognitive outcomes, as well as brain changes, in this population. Participants will receive daily rTMS treatment targeted to the left dorsolateral prefrontal cortex lDLPFC at 10 Hz frequency, with two sessions per day over 20 business days for four weeks. The location of stimulation is personalized using an algorithm based on brain connectivity. There is also a comparison group receiving sham stimulation with the coil placed on the vertex, following the same schedule and intensity. During the study, participants will undergo cognitive testing and brain imaging at baseline, after the 4-week treatment, and at 6-month follow-up to measure changes in executive functions and brain connectivity. Clinical outcomes, including alcohol craving and symptoms of anxiety and depression, will be monitored throughout. The study lasts about six months from baseline to final follow-up, with safety and treatment adherence carefully observed.

This research aims to evaluate the effects of immediate postoperative bevacizumab administration in patients with proliferative diabetic retinopathy undergoing vitrectomy surgery. The study focuses on individuals with type I or II diabetes who require surgery to address complications such as non-clearing vitreous hemorrhage, tractional retinal detachment, or fibrovascular proliferation affecting vision. The goal is to compare outcomes between those who receive bevacizumab right after surgery and those who do not. Participants will be randomly assigned to one of two groups one group will receive an injection of bevacizumab immediately after their vitrectomy, while the other group will not receive this treatment. The surgery involved is pars plana vitrectomy, performed to improve vision affected by the diabetic eye complications. This is a double-blind study, meaning neither the participants nor the researchers know who receives the drug or not during the trial. During the study, participants will be followed and assessed for six months after surgery. Researchers will monitor their vision using tests such as the best-corrected spectacle visual acuity on the Snellen chart. They will also evaluate the safety and effectiveness of the treatment, looking for any changes or complications. Participants will attend scheduled visits to support ongoing monitoring and outcome measurement over this period.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

Researchers are evaluating the long-term safety of nivolumab alone or in combination with other cancer therapies in patients with various tumor types. This Phase 2 study focuses on monitoring the effects and side effects of these treatments over an extended period to understand their safety profiles better. Participants receive one of several treatment regimens involving drugs such as nivolumab, ipilimumab, cabozantinib, trametinib, relatlimab, and others. Each treatment is given at specified doses on set days, with some regimens combining multiple drugs. The study includes patients who have previously participated in Bristol-Myers Squibb sponsored trials and may continue or restart treatment based on prior response. Throughout the study, participants undergo regular safety assessments to track adverse events, including serious, immune-mediated, and drug-related side effects. Monitoring continues from the first day of treatment up to 135 days after stopping treatment to assess the incidence of adverse events and deaths. This comprehensive safety monitoring helps researchers understand the long-term effects of these cancer therapies over several years.