Guadalajara

Researchers are evaluating the efficacy and safety of eloralintide in adults with moderate-to-severe obstructive sleep apnea who are also overweight or obese. This trial is structured as a master protocol called YDAO, which supports two studies YSA1 for participants who do not use or refuse Positive Airway Pressure PAP therapy, and YSA2 for those who have been on PAP therapy for at least three months and plan to continue it. The study aims to understand how eloralintide affects body weight and sleep apnea severity over time. Participants will be randomly assigned to receive either eloralintide or a placebo through subcutaneous injections once weekly. The study includes two parallel groups reflecting current PAP therapy use. Treatment lasts about 64 weeks, followed by assessments. The design includes double-blinding to compare the effects between intervention and placebo groups. During the study, participants will be closely monitored for changes in body weight and apnea-hypopnea index AHI at baseline and week 64. Additional measurements include blood pressure, triglycerides, inflammation markers, sleep-related impairment scores, and glucose metabolism. Researchers will also track patient-reported outcomes, medication use, and pharmacokinetics. Participation lasts approximately 76 weeks, covering screening, treatment, and follow-up evaluations to ensure safety and collect comprehensive data.

Researchers are conducting an observational study to assess patient satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in people with certain types of lung cancer and hepatocellular carcinoma. The study focuses on participants treated for approved indications in routine clinical practice across multiple countries and centers. It collects primary data on patient-reported outcomes and clinical effectiveness in real-world settings. Participants receive Atezolizumab as prescribed by their doctors for conditions including early-stage non-small cell lung cancer NSCLC after surgery and chemotherapy, metastatic NSCLC, extensive-stage small cell lung cancer ES-SCLC, and advanced or unresectable hepatocellular carcinoma HCC. Atezolizumab administration is at the physicians discretion and is independent of study participation. The study includes several cohorts based on cancer type and stage. During the study, participants report treatment satisfaction using the Therapy Administration Satisfaction Questionnaire Subcutaneous TASQ-SC at cycles 2 and 3, each lasting 3 weeks. Researchers also evaluate overall survival up to about 3.5 years, quality of life with the EORTC QLQ-C30 questionnaire, and record adverse events during the same period. The study aims to monitor patient experience, clinical outcomes, and safety over the long term, with participation lasting several years.

Researchers are evaluating the effects of NNC0487-0111 in adults with excess body weight and obstructive sleep apnea who are not using positive airway pressure treatment. This Phase 3 trial aims to assess the safety and effectiveness of this medication in helping participants lose weight and improve their sleep apnea. The study compares NNC0487-0111 with a placebo, which is an inactive treatment given by chance to participants. Participants receive weekly injections of either NNC0487-0111 or a matching placebo under the skin using pre-filled pen injectors applied to the thigh, abdomen, or upper arm. Both groups follow a reduced-calorie diet and increase physical activity during the study. The treatment period lasts for 80 weeks, during which researchers monitor changes in body weight and sleep apnea severity. Throughout the study, participants undergo regular assessments including body weight measurements and evaluation of the apnea-hypopnea index AHI to track sleep apnea severity. Additional tests measure sleep-related impairment, blood pressure, cholesterol levels, and blood sugar control. Safety is monitored by tracking any adverse events during the 84 weeks of the study. Participants progress is carefully followed to understand the impact of the treatment on weight and sleep apnea over time.

Researchers are evaluating the effectiveness and safety of NNC0487-0111 in adults with overweight or obesity who also have obstructive sleep apnoea and are being treated with positive airway pressure. This phase 3 study compares NNC0487-0111 to a placebo, which contains no active medicine, to see how well the treatment helps with weight loss and improvement in sleep apnoea symptoms. Participants will receive one of two dose levels of NNC0487-0111 or a matching placebo as weekly injections under the skin. These injections are given alongside a reduced-calorie diet and increased physical activity. The treatment is administered using pre-filled pen injectors to the thigh, abdomen, or upper arm, and the study lasts for 80 weeks. Throughout the trial, participants will be monitored regularly to assess changes in body weight, sleep apnoea severity measured by the apnoea-hypopnoea index AHI, and other health measures such as waist and neck circumference, blood pressure, cholesterol, blood sugar, and sleep quality scores. Safety is tracked by recording any treatment-related adverse events. The study runs until week 80, with follow-up continuing through week 84 to evaluate ongoing safety and effectiveness.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

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.

This observational clinical follow-up study is designed to evaluate the safety of immunotherapy for treating hymenoptera venom allergy in real-life conditions. It focuses on patients allergic to venom from Apis mellifera bee or Vespula spp. wasp and includes the assessment of both controlled and spontaneous stings. The study is multicentric and will be conducted in Spain with prospective data collection. Participants will receive VENOX immunotherapy, an allergy vaccine targeting venom from wasps or bees, as per clinical recommendations. The study will follow patients for 12 months to monitor safety and tolerability, particularly the incidence of treatment-emergent adverse reactions. It also evaluates treatment effectiveness after reaching a maintenance dose and assesses immunological parameters and quality of life using the SEAIC questionnaire. During the study, participants will be observed over one year with regular follow-ups to collect data on adverse reactions and treatment impact. Researchers will monitor spontaneous natural stings and measure immunological changes. Quality of life related to venom allergy will also be assessed. The total number of participants is expected to be 80, all aged 14 years or older, and of any gender.

Researchers are conducting a long-term observational study to collect information from patients diagnosed with early-stage invasive breast cancer. These patients were previously part of neoadjuvant or adjuvant clinical trials conducted by the GEICAM group, starting from 1998. The study aims to evaluate the long-term effects and outcomes of breast cancer treatments over an extended follow-up period. The study includes patients who completed follow-up in the original GEICAM trials and will continue to monitor them for approximately 30 years. This extended observation allows researchers to assess long-term event-free survival and disease-free survival, along with overall survival, providing valuable insights into the durability of treatment effects and potential late effects. Participants will be followed regularly during this period, with data collected to track their health status and cancer outcomes. The study gathers vital information useful for healthcare professionals, hospital managers, patients, and society to better understand long-term needs and treatment impacts in early-stage invasive breast cancer. The total participation duration can be up to 30 years from the start of the study.

Inflammatory bowel disease IBD, including ulcerative colitis UC and Crohns disease CD, involves chronic inflammation affecting the digestive tract with periods of flare-ups. This study evaluates the real-world effectiveness and safety of granulocytapheresis GMA using the Adacolumn device in adult patients with UC or CD. GMA selectively removes inflammatory cells from the blood to reduce inflammation and is considered as an alternative or complementary treatment to corticosteroids and biological therapies in IBD management. Participants will receive GMA treatment with Adacolumn, typically following the standard regimen of one session per week for five weeks. In some cases, induction regimens with two sessions per week or maintenance regimens with one to two sessions per month may be used. The study is noninterventional and conducted across about 30 sites, aiming to enroll approximately 350 patients. Treatment use and regimens will be observed according to routine clinical practice without interfering with patient care. Patients will be followed through up to four visits baseline, and follow-ups at about 1 month, 6 months, and 12 months after the last induction session. Data collection includes clinical remission rates, steroid use, adverse events, quality of life assessments, and biomarker changes. All assessments coincide with routine care visits. The primary outcome is the proportion of patients achieving steroid-free remission at six months, with additional secondary outcomes evaluating remission rates, treatment regimens, safety, and quality of life over 12 months.

The trial investigates treatment options for adults with newly diagnosed multiple myeloma who are eligible for stem cell transplantation. It is a Phase III, open-label, randomized study comparing three treatment approaches to evaluate their effectiveness in achieving minimal residual disease negativity using next-generation flow cytometry. The study aims to compare an extended VRD regimen plus early rescue intervention with two Isatuximab-containing regimens. Participants are assigned to one of three groups Arm A receives Isatuximab combined with VRD followed by autologous stem cell transplant ASCT, then consolidation and continuous treatment with Lenalidomide and monthly Isatuximab Arm B receives an extended VRD regimen with ASCT plus early rescue intervention involving Isatuximab-Iberdomide-Dexamethasone, followed by consolidation and continuous treatment with adjusted VRD cycles Arm C is treated with Isatuximab, Iberdomide, VRD, and ASCT, followed by consolidation and continuous treatment with Iberdomide and monthly Isatuximab. Each treatment phase includes induction, ASCT, consolidation, and continuous therapy lasting approximately 24 months or longer. Throughout the study, participants undergo multiple cycles of treatment with frequent dosing schedules, including intravenous infusions and oral medications. Researchers assess the primary outcome by measuring the proportion of participants who are MRD-negative after 18 cycles plus ASCT, approximately 24 months. Safety and progression-free survival are monitored over about 78 months. The study also involves bone marrow analyses, adherence tracking, and reviews of therapeutic programs up to 36 months. Participants are followed closely for treatment response and adverse events during and after therapy.