Cuiaba

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after prior therapy. The study aims to find out if the combination of belzutifan and zanzalintinib can help people with recurrent advanced RCC live longer without their cancer worsening compared to the drug cabozantinib. This is a phase 3 randomized trial evaluating these treatments in participants who have experienced recurrence during or after prior anti-PD-1L1 therapy. Participants are randomly assigned to receive either belzutifan plus zanzalintinib taken orally once daily or cabozantinib taken orally once daily. They continue their assigned treatment until certain reasons require stopping the study intervention. The study compares the effects of these treatments on cancer progression and survival among people with advanced RCC who have had disease recurrence after adjuvant therapy. During the study, participants will be regularly monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also assess tumor response, duration of response, adverse events, and quality of life using questionnaires over approximately 25 months. The study involves ongoing evaluations to understand how these treatments affect symptoms, functioning, and overall health during long-term follow-up.

Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus SLE who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab GSK1550188 administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State LLDAS at week 52 and other measures such as the SLE Responder Index 4 SRI4, flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the drug Deucravacitinib BMS-986165 in children and adolescents aged 5 to less than 18 years who have juvenile psoriatic arthritis. This Phase 3 trial aims to study the drugs levels in the body, how well it works, and its safety for this specific pediatric population. The trial is designed as a randomized withdrawal study comparing Deucravacitinib to placebo. Participants receive Deucravacitinib or placebo according to a specified dosing schedule. The study includes an initial treatment period followed by a withdrawal phase to monitor for disease flare. Key outcomes measured include time to first flare during the withdrawal period, drug concentration levels at steady state, achievement of low disease activity or inactive disease, and safety events such as adverse effects and uveitis occurrence. Throughout the study, participants will undergo clinical assessments including joint evaluations, disease activity scores, and psoriasis severity scales. Researchers will monitor for disease flares, remission status, and adverse events up to week 42. The trial includes pharmacokinetic analyses and evaluates participant-reported measures like taste and swallowability of the medication. Participation spans from screening through treatment and follow-up to capture comprehensive safety and efficacy data.

This research aims to evaluate how active health education methods can increase the number of schoolchildren getting the HPV vaccine. The study addresses a recent drop in HPV vaccine adherence among young people in Brazil. It involves 80 schools and 5,000 students, using a stepped-wedge design where clusters of schools are randomized every two months to one of four different interventions. The study compares four approaches active training for both students and teachers, active training for students only, a nurse-led vaccination orientation session in schools, and usual care without specific interventions. Teacher training includes 30 hours of online self-instruction focused on vaccination, while students receive education and active vaccination efforts over two months. Each intervention is applied to clusters of schools in a randomized sequence. Participants are schoolchildren aged 9 to 14 years. Researchers will measure vaccination rates, including the proportion receiving at least one dose and those completing the full HPV vaccine series, along with tracking vaccination refusals among students and teachers over 12 months. The study monitors these outcomes following the interventions to understand their impact on vaccine coverage and refusal rates.

Researchers are evaluating the safety and effectiveness of AlloNK, a non-genetically modified allogeneic natural killer NK cell therapy derived from cord blood, combined with rituximab, in people with relapsing forms of B-cell dependent rheumatologic diseases. These diseases include refractory rheumatoid arthritis, Sjgrens disease, idiopathic inflammatory myopathies, and systemic sclerosis. This open-label Phase 2a study aims to explore treatment options for patients whose conditions have not responded well to previous therapies. Participants receive AlloNK after a conditioning regimen, followed by rituximab. AlloNK is an off-the-shelf, cryopreserved NK cell therapy given in combination with rituximab. The treatment period lasts up to 104 weeks, during which participants are monitored for safety and clinical response. The study includes one treatment group receiving this combination therapy. Throughout the study, participants undergo regular assessments to evaluate safety from enrollment until the end of treatment at Week 104. Researchers measure disease-specific outcomes at Week 52, including disease activity scores for rheumatoid arthritis, Sjgrens disease activity indices, improvement scores for inflammatory myopathies, and response indices for systemic sclerosis. The study involves clinical evaluations, laboratory tests including inflammatory markers, and joint assessments to monitor treatment effects and safety over the extended period.

Researchers are tracking patients with Fabry disease through an ongoing international observational program called the Fabry Registry. This registry collects routine clinical outcomes for patients regardless of whether they are receiving treatment. The study aims to better understand the diseases variability, progression, and natural history, including in women who carry one copy of the gene, and to help improve patient care by developing monitoring recommendations and reporting outcomes. Additionally, the registry evaluates the long-term safety and effectiveness of Fabrazyme4, a treatment used in Fabry disease. The registry includes a special pregnancy sub-registry for women with Fabry disease who are pregnant or have been pregnant. This sub-registry observes pregnancy outcomes and infant growth up to 36 months after birth, collecting medical and obstetric history and treatment details. No experimental treatments are given participants continue to receive their usual care as determined by their physicians. Data from both registries support regulatory requirements and ongoing research. Participants undergo regular clinical assessments and receive standard care from their doctors throughout the study. The research team collects data on disease progression, treatment effectiveness, pregnancy outcomes, and infant development. The study is observational, meaning no study drugs or procedures are administered. The total participation can last up to 33 years, allowing for long-term monitoring of safety and outcomes related to Fabry disease and pregnancy.

This research aims to collect detailed information about Pompe disease, a rare genetic disorder also known as Glycogen Storage Disease Type II. The study is a global, long-term observational program designed to better understand the diseases progression, variability, and identification in patients who are either treated or untreated. It also supports regulatory requirements, product development, reimbursement, and other research purposes. Participants in the Pompe Registry are tracked over many years, up to 30 years, to observe the natural history of the disease and evaluate long-term outcomes, including the effects of treatments like alglucosidase alfa. This observational study does not involve experimental treatments but gathers data from patients worldwide to improve care strategies and recommendations. During the study, participants health information is collected retrospectively and prospectively, including clinical outcomes and disease manifestations. Researchers analyze these data to understand patient variability, disease progression, and treatment effectiveness. The registry helps develop guidance for monitoring patients and provides valuable insights to optimize Pompe disease care over an extended period.