Santarem

Researchers are investigating the effectiveness and safety of a sublingual immunotherapy called MM09 for treating people aged 12 to 65 with moderate-to-severe allergic rhinitis or rhinoconjunctivitis caused by house dust mites (Dermatophagoides pteronyssinus and/or Dermatophagoides farinae). The study also includes participants with or without mild-to-moderate controlled asthma. This phase III, randomized, double-blind, placebo-controlled trial aims to see if MM09 can reduce symptoms and the need for rescue medication compared to a placebo. Participants receive a sublingual spray of MM09 at a dose of 30,000 TU/mL or a placebo for 12 months. The treatment is given daily under the tongue. The trial is conducted at multiple centers and includes careful monitoring of participants throughout the treatment period. Researchers will observe participants for any medical problems that occur when inhaling MM09 and compare results with those receiving the placebo. During the study, participants will use a smartphone to record their symptoms and medication use. Researchers will assess the combined symptom and medication score during the last four weeks of treatment to evaluate effectiveness. Safety assessments and monitoring for adverse effects will also be conducted. The total duration of participation includes the 12-month treatment period with ongoing evaluations to understand MM09's impact on allergic rhinitis, rhinoconjunctivitis, and asthma symptoms.

Research supports that an active lifestyle helps prevent and treat pregnancy-related health issues such as gestational diabetes, hypertension, obesity, low back pain, urinary incontinence, anxiety, and depression. It also helps maintain fitness, functionality, and improves postpartum recovery. Despite this knowledge, many pregnant and postpartum women lack proper exercise guidance, and physical inactivity remains common. The COVID-19 pandemic has increased the need for virtual health programs, but few studies have evaluated their effectiveness compared to in-person options. This trial compares in-person versus online supervised prenatal exercise programs for pregnant women between 13 and 20 weeks gestation without contraindications to exercise. The 12-week program includes aerobic, coordination, strength, postural, stretching, balance, and pelvic floor exercises delivered by qualified exercise physiologists. Sessions occur twice weekly for 60 minutes and follow international guidelines. Participants can attend in person at fitness centers, universities, or hospitals, or join online from home. Participants complete questionnaires and fitness tests before and after the 12-week program to assess physical activity, fitness, and healthy lifestyle factors like sleep, diet, and stress. Researchers measure outcomes including strength, balance, flexibility, agility, and cardiorespiratory fitness. They will also evaluate satisfaction with the intervention and educational resources such as the Active Pregnancy Guide and YouTube channel. The study aims to inform future exercise recommendations and public health strategies for pregnant women.

Researchers are evaluating the long-term reliability and performance of Medtronic cardiac rhythm products, including leads and devices used for pacing, sensing, or defibrillation. The study aims to analyze product survival probabilities to better understand their durability and performance over time. This research includes all Medtronic market-released leads and implantable devices for conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. Participants include those who have been implanted with at least one Medtronic market-released product or those who participated in qualifying Medtronic studies with complete implant and follow-up data. The study monitors these devices from the time of implant, tracking lead-related complications and device performance. If a patient exits the study, passes away, or the device is deactivated, the implant is no longer followed. During the study, researchers collect health information and monitor the devices to assess ongoing performance and complications. Follow-up is essential to confirm device status and ensure accurate data collection. The main outcome measured is lead-related complications for each lead model, with continuous observation from implant until termination due to patient or device status. Participation requires informed consent and authorization for access to health information as per institutional requirements.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.