Natick

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

This research aims to understand how eating food items containing shelf-stored tart cherry affects the body's ability to absorb and use the compounds found in tart cherry. The study focuses on active-duty military personnel and civilians aged 17 to 39, exploring the bioavailability of polyphenols after consuming tart cherry products. Previous evidence suggests that tart cherry may benefit muscle health by reducing damage, soreness, and inflammation from exercise, but this study first assesses how well the body absorbs these compounds from different tart cherry food items. Participants will take part in a randomized, crossover study where they consume four different food products across separate sessions: a commercial tart cherry juice, a tart cherry powder snack bar, a tart cherry powdered drink, and a placebo beverage without tart cherry. Each session is followed by a five-day washout period. Blood samples will be collected before and at multiple times after consumption to measure blood levels of polyphenols and related antioxidant markers. The tart cherry treatments are matched by anthocyanin content to compare absorption across items. During the study, participants will undergo procedures including an overnight fast, insertion of an IV catheter for blood draws, and adherence to a low-polyphenol diet before sessions. Researchers will monitor blood and urine for polyphenol levels and antioxidant capacity, and study the relationship of these outcomes to gut microbiome composition. The main outcome is the measurement of polyphenol levels in plasma at various times up to 24 hours after consumption. The study plans to enroll up to 15 participants who comply with all procedures and medical clearances.

Researchers are investigating how consuming energy-dense bars with different macronutrient compositions affects aerobic performance and substrate use during cold exposure. This randomized crossover study focuses on healthy adults aged 18 to 39 years who will be exposed to cold conditions (5°C) while wearing shorts and a t-shirt. The study aims to understand how bars higher in carbohydrate or fat impact endurance and energy use during physical activity in cold environments. Participants will consume one of two isocaloric bars (about 350 kcal), one higher in carbohydrates (50% carbohydrate, 30% fat, 20% protein) and the other higher in fat (30% carbohydrate, 50% fat, 20% protein). After consumption, they will rest for 60 minutes in cold conditions to induce physiological responses. They will then complete 90 minutes of treadmill exercise carrying a load equal to 30% of their body mass at a steady intensity, followed by a 2-mile time trial to assess aerobic performance. The order of bar consumption will be randomized, with a minimum 6-day washout between trials. Throughout the study, researchers will collect baseline measurements including height, weight, body composition, and peak oxygen uptake. During exercise, substrate oxidation will be measured using indirect calorimetry, and blood samples will be taken to monitor substrate and hormone responses. Diet and exercise will be controlled before and during the study days. This comprehensive monitoring will help evaluate endurance performance and how the body uses energy substrates under cold stress and different nutritional conditions.

Researchers are studying how long-acting reversible contraceptives (LARCs), such as implants or intrauterine devices (IUDs), affect iron levels and the body's responses to extreme environments like heat, cold, and high altitude in women. The study focuses on female military service members and civilians aged 18 to 40 who use LARCs or monophasic oral contraceptives. This is important because iron deficiency is common in U.S. military women and may influence health and performance, and LARCs might help preserve iron by reducing menstrual blood loss. Participants will undergo testing to measure blood volume, iron stores, and physiological responses during separate exposures to heat, cold, and high altitude. Heat stress testing includes measuring core body temperature, skin temperature, and sweat rate in hot, humid conditions. Cold stress testing assesses core temperature, metabolic heat production, skin blood flow, and temperature during a 90-minute exposure to cold air (around 106C). At high altitude (4300m), cardiopulmonary responses will be measured during rest and exercise. Blood samples will be collected to evaluate sex hormones, iron status, and inflammation. During the study, participants will be monitored through various tests including ventilation, heart rate, skin blood flow, and core temperature measured intermittently across each environmental exposure. Sweating rate is measured immediately after exercise in heat stress. Blood samples and specialized laboratory tests will help assess changes in iron stores and physiological reactions. Total participation involves multiple visits with at least 48 hours between environmental testing sessions, and exposure to an altitude chamber for about 6 hours during high-altitude testing.

Researchers are evaluating how intravenous iron compared to a placebo affects oxygen levels in the blood, exercise responses, and 2-mile treadmill performance during sudden exposure to high altitude conditions simulating about 4800 meters. The study aims to see if iron treatment improves oxygen saturation and physical performance at high altitude and whether these effects last for two weeks. This is a Phase 4, double-blind, randomized study involving healthy adults aged 18 to 40 years. Participants will be divided into two groups: one receiving an intravenous iron injection (Injectafer, 15 mg/kg up to 1000 mg) and the other receiving a saline placebo. The study includes seven visits: an orientation with scans and fitness tests, two familiarization sessions with exercise tests, the iron or placebo injection, and three visits at high altitude where various measurements such as skin blood flow, ventilation, blood samples, and exercise performance are assessed. During the study, participants will undergo pulmonary function tests, aerobic capacity assessments, blood collections at sea level and high altitude, and treadmill trials including a 2-mile time trial. Researchers will monitor arterial oxygen saturation at rest and during exercise, exercise performance, and other physiological responses before, during, and after the high altitude exposure. The total participation includes baseline, intervention, and follow-up assessments over the study visits.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are studying how different amounts of dietary protein affect muscle protein synthesis in healthy, recreationally active men and women aged 17 to 39 years during a period of muscle disuse caused by knee immobilization. This study focuses on muscle loss after musculoskeletal injuries, which happens due to reduced muscle activity and a decrease in muscle protein building. The goal is to find the best protein dose to improve muscle recovery during disuse and help develop nutritional strategies to preserve muscle mass and enhance recovery outcomes. Participants will undergo five days of muscle disuse using a knee brace fixed at about 60 degrees of flexion on one leg, while the other leg remains active as a control. They will walk using crutches and follow a standardized diet during immobilization. At the end of this period, they will receive either 20 grams or 40 grams of whey protein in beverage form. Muscle protein synthesis will be measured in both legs using stable isotope infusions, blood tests, and muscle biopsies to compare the effects of the two protein doses. During the study, participants will have regular assessments including blood draws and muscle biopsies. Researchers will measure muscle protein synthesis rates in both the immobilized and active legs after protein intake. Participants must follow dietary and activity restrictions, and their adherence will be monitored. The study aims to better understand how protein intake influences muscle recovery during short-term disuse, providing important information for improving rehabilitation after injury.

Heart failure with preserved ejection fraction (HFPEF) is a common and serious condition without effective treatment options. Researchers are evaluating whether adding spironolactone, a medication, to standard care can reduce the combined risk of cardiovascular death and hospitalizations for heart failure in patients with HFPEF. This study is a Phase 3 trial including patients from the Swedish Heart Failure Registry and the US, all having symptoms of heart failure, elevated heart-related blood markers, and an ejection fraction of 40% or higher. Participants are randomly assigned to one of two groups: one receiving spironolactone along with usual care, and the other receiving usual care alone without spironolactone. The study is designed as a registry-randomized clinical trial and will continue until 721 cardiovascular death or heart failure hospitalization events occur, with an enrollment period of 7 years and a total study duration of 9 years. Data collection in Sweden uses registry linkages, while data in the US comes from site reports and supplemented call center follow-up. During the study, researchers will monitor participants for hospitalizations due to heart failure or cardiovascular death as the primary outcome. Secondary outcomes include other hospitalizations, side effects, and how well patients follow their treatment plans. Outcomes are tracked through national registries and direct reporting, with the main data locked and analyzed five years after the study begins. Approximately 2000 patients aged 50 to 99 years will be included to achieve the event target needed for study conclusions.