Senhora Da Hora

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation linked to Alzheimers Disease. This phase 3 trial aims to understand how these treatments impact agitation symptoms in this population. The study is sponsored by Bristol-Myers Squibb and uses rigorous methods to compare the investigational drugs against a placebo. Participants will receive either the combination of XanomelineTrospium Chloride capsules KarXT KarX-EC or a placebo, with doses given on specified days. The study is randomized, double-blind, and placebo-controlled, ensuring objective assessment of treatment effects over a 14-week period. The trial includes a parallel group design where participants are assigned to either the experimental treatment group or placebo group. During the study, participants will be assessed for changes in agitation using the Cohen-Mansfield Agitation Inventory and other related scales at week 14. Researchers will monitor safety through adverse event reports, clinical labs, vital signs, ECGs, and specific rating scales up to week 18. Caregivers will assist by attending visits and reporting on participant status. Total participation involves regular visits and assessments over the course of the trial.

Researchers are evaluating how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes T2D, lose weight. The purpose of this clinical study is to find out how safe and effective CagriSema is for body weight loss compared to semaglutide, a medicine already prescribed by doctors. This is a Phase 3 randomized trial lasting about 83 weeks. Participants will be randomly assigned to receive either one of two doses of CagriSema or semaglutide, all given once weekly by injection under the skin during a 72-week treatment period. CagriSema is a new medicine being tested, while semaglutide serves as an active comparator. The study compares these treatments for their effects on weight loss and related health measures. During the study, participants will have regular assessments including body weight, body mass index BMI, waist circumference, cholesterol levels, and blood sugar control measured by HbA1c. Researchers will also monitor physical function and quality of life through questionnaires. Safety is tracked by recording any adverse events up to 80 weeks. The main outcome is the change in body weight from the start of treatment to the end of the 72-week period.

This research aims to evaluate the effectiveness and safety of lebrikizumab in people with chronic rhinosinusitis and nasal polyps who are also treated with intranasal corticosteroids. The study is a Phase 3 clinical trial lasting about 18 months and includes participants aged 12 years and older. It is designed to understand how lebrikizumab works alongside standard nasal spray treatment for this condition. Participants will receive lebrikizumab through subcutaneous injections every 2, 4, or 8 weeks, depending on the assigned group. All participants continue using their regular intranasal corticosteroid sprays during the study. Adolescents aged 12 to under 18 years will receive open-label lebrikizumab injections every 2 or 4 weeks. There is also a placebo group receiving injections without the active drug but with the same nasal spray background treatment. During the study, participants will be monitored regularly for changes in nasal congestion and nasal polyp size over 24 weeks, using participant reports and endoscopic examinations. Other assessments include sinus imaging, lung function tests, smell loss severity, postnasal drip symptoms, and quality of life questionnaires. Safety and adherence will be closely observed throughout the 18-month study period to ensure participant well-being.

This research aims to evaluate the effects of telisotuzumab adizutecan, an investigational drug, compared to standard treatments in adults with locally advanced or metastatic EGFR-mutated non-squamous non-small cell lung cancer NSCLC who have progressed after third-generation EGFR TKI therapy. The study includes two stages a phase 2 dose-finding period and a phase 3 randomized comparison. Approximately 430 adults will participate across about 200 sites worldwide, with the study lasting approximately 69 months. In phase 2, participants receive one of two intravenous doses of telisotuzumab adizutecan. In phase 3, participants are randomly assigned to receive either the recommended phase 3 dose of telisotuzumab adizutecan or the investigators choice of standard of care SOC. Treatments are delivered via IV infusion throughout the study period. The trial is open-label and aims to compare safety and disease activity outcomes between the drug and SOC. Participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure objective response, progression-free survival, overall survival, duration of response, disease control, and quality of life, including physical functioning and lung cancer symptoms. These assessments will be conducted up to about 69 months, with some quality of life measures evaluated up to week 12.

Researchers are evaluating the long-term safety and effectiveness of a combined treatment using xanomeline tartratetrospium chloride in an immediate release capsule KarXT and xanomeline enteric capsules KarX-EC for people with agitation associated with Alzheimers Disease. This study includes participants who have completed previous related studies CN012-0023 or CN012-0024. The goal is to observe how well these treatments work and how safe they are over an extended period. The study involves giving participants specified doses of KarXT and KarX-EC on certain days. This is an open-label study, meaning both the researchers and participants know what treatment is being given. The trial is non-randomized and does not include a placebo group. The treatment period lasts up to about 30 weeks, during which participants take the study medications and are closely monitored. Participants will be involved in regular assessments throughout up to approximately 30 weeks. Researchers will track any treatment-emergent side effects and other adverse events, along with specific measures such as movement scales, body weight and BMI changes, heart rate and blood pressure checks, laboratory tests, ECGs, and cognitive assessments like the Mini-mental State Examination and ADAS-Cog. Safety monitoring includes assessment of suicidal thoughts and prostate symptom severity. This comprehensive monitoring aims to understand the treatment impacts and participant safety during the study.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

Researchers are evaluating the effects of the medicine BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. This study includes people with or without type 2 diabetes and those who may or may not be taking certain blood pressure medicines such as ACE inhibitors or ARBs. The goal is to understand if adding BI 690517 to empagliflozin helps reduce the risk of kidney failure, heart disease, or hospitalization due to heart failure. The study has two parts. In the first part, all participants receive empagliflozin or a placebo similar to BI 690517 for at least six weeks while continuing any indicated ACEi or ARB treatments. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the remainder of the study. The study lasts about three to four years until enough events related to kidney or heart health occur. During the study, participants visit the study site about four times in the first six months and then every six months afterward. At these visits, doctors check health status, collect blood and urine samples, measure blood pressure and weight, assess kidney function, and monitor any side effects. Researchers track the time until worsening kidney disease, heart failure hospitalizations, or cardiovascular death to compare outcomes between treatment groups.

Researchers are evaluating the safety and effectiveness of ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab in adults with first-line PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma HNSCC. This study focuses on targeting two cancer drivers, EGFR and TGF-, which promote tumor growth and spread. The research is conducted in two phases to identify the best dose and compare treatment outcomes. In Phase 2, participants are randomly assigned to one of three groups high-dose ficerafusp alfa with pembrolizumab, lower-dose ficerafusp alfa with pembrolizumab, or placebo with pembrolizumab. Phase 3 compares the chosen optimal dose of ficerafusp alfa plus pembrolizumab against placebo plus pembrolizumab with a 21 randomization ratio. Treatments are given weekly or every three weeks according to the study arm. Participants will undergo regular evaluations including scans to measure tumor response, safety monitoring for side effects, and quality of life assessments. The study measures outcomes such as tumor response rate, overall survival, progression-free survival, and treatment safety over periods ranging from one to three years. Researchers will also monitor treatment-related adverse events and the impact on symptoms and pain throughout the study.

Researchers are evaluating palazestrant OP-1250 compared to standard endocrine therapies for adults with ER-positive, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine therapy combined with a CDK46 inhibitor. This international phase 3 trial aims to assess the safety and effectiveness of palazestrant versus fulvestrant or aromatase inhibitors such as anastrozole, letrozole, or exemestane. Participants are randomly assigned to receive either palazestrant daily on a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or the standard-of-care endocrine therapy including fulvestrant administered on specific days or one of the aromatase inhibitors given daily on similar cycles. The trial includes an initial dose-selection period with about 120 participants, followed by a larger randomized phase with approximately 390 participants receiving the selected dose of palazestrant or standard treatment. Throughout the study, participants will be monitored for adverse events, dose adjustments, and drug discontinuations up to 16 weeks. Researchers will measure progression-free survival for up to two years and overall survival for up to four years after randomization. Regular assessments will include clinical evaluations and safety monitoring to observe the effects and tolerability of the treatments during the trial.

Researchers are evaluating BHV-7000 as a possible treatment for adults with refractory focal onset epilepsy, a condition where seizures originate in a specific part of the brain and have not responded to standard medications. This Phase 23 study is designed to assess whether BHV-7000 can reduce seizure frequency compared to a placebo, while also monitoring its safety and tolerability. Participants in this randomized, double-blind trial will receive either BHV-7000 at doses of 50 mg or 75 mg, or a matching placebo, taken once daily. The study spans from baseline through weeks 8 to 16, during which seizure frequency and other outcomes will be evaluated. The treatments are blinded, meaning neither participants nor researchers know which group the participants are in during the study. Throughout the study, participants will keep detailed seizure diaries to track seizure frequency. Researchers will measure changes in average seizure frequency over 28 days, along with other outcomes such as the percentage of participants experiencing significant reductions in seizures or seizure freedom. Safety will be monitored by recording adverse events and laboratory tests. The total participation period covers treatment and follow-up up to week 16 after baseline.