Calgary

Preterm birth before 37 weeks' gestation is common and linked to many health challenges, especially when it occurs before 29 weeks. At this early stage, infants often face breathing difficulties due to immature lungs, sometimes requiring resuscitation. This study aims to compare two oxygen concentrations, 30% and 60%, used during resuscitation of very preterm infants to determine which leads to better survival and neurodevelopmental outcomes by about two years of age. The study uses a cluster randomized crossover design, where hospitals alternate between using 30% and 60% oxygen to resuscitate infants born between 23 and 28 weeks gestation. Infants receive the assigned oxygen concentration for the first 5 minutes after birth, with adjustments made based on oxygen saturation levels to maintain safe ranges. The intervention lasts 10 minutes, including initial resuscitation and oxygen titration to stabilize the infant. Participants will be closely monitored during their hospital stay and followed up at 24 months corrected age to assess survival and major neurodevelopmental outcomes. Data collected will include oxygen saturation, heart rate during resuscitation, and longer-term health measures. The study's results aim to guide safer oxygen use in resuscitating extremely preterm infants worldwide.

Researchers are evaluating whether 68Ga-HA-DOTATATE PET/CT imaging is effective for diagnosing somatostatin positive neuroendocrine tumors compared to conventional imaging methods such as CT, MRI, 111 In-pentetreotide Scans, and 18F-FDG PET/CT. This study aims to assess the usefulness of 68Ga-HA-DOTATATE in the initial workup of neuroendocrine tumors, including suspected cases without clear imaging correlates. It also explores the role of this imaging in monitoring tumors that have been completely removed and in locating functioning neuroendocrine tumors like insulinoma and gastrinoma. Each patient will receive an intravenous injection of 100-250 MBq of 68Ga-HA-DOTATATE. Imaging will start 45-90 minutes after the injection. After completing the PET scan, a CT scan will be performed without moving the patient to provide additional localization and correction. The results of the 68Ga-HA-DOTATATE PET/CT will be compared with any previous imaging and pathological findings. Participants will undergo imaging and clinical evaluations during the study. Researchers will monitor the imaging results over a 5-year period to assess the effectiveness of 68Ga-HA-DOTATATE PET/CT for diagnosis and surveillance. The main outcome measured is the diagnostic performance of this imaging method compared to standard techniques. Participants will be asked to comply with study instructions and provide informed consent prior to enrollment.

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.

Researchers are investigating the safety and tolerability of an investigational drug called PGN-EDODM1 in adults with myotonic dystrophy type 1 (DM1), a genetic condition characterized by muscle weakness and myotonia. This Phase 2 study compares multiple doses of PGN-EDODM1 to a placebo, aiming to understand how well the drug is tolerated and its potential effects in people with this condition. Participants will receive PGN-EDODM1 or placebo through intravenous (IV) infusions. The study is randomized, double-blind, and placebo-controlled, with multiple ascending dosing to evaluate safety across different dose levels. Both treatments are administered by IV infusion, and the study includes adult participants aged 16 to 65 years with confirmed DM1. During the study, researchers will monitor participants closely for any adverse events from the start of treatment through Day 112 to assess safety and tolerability. This includes physical exams, muscle biopsies, laboratory tests, and other clinical assessments to track participant health and response to treatment. The total duration of participation covers the dosing period and follow-up assessments to ensure comprehensive safety monitoring.

Researchers are evaluating sotatercept as a potential treatment for pulmonary arterial hypertension (PAH), a condition where blood vessels in the lungs thicken and narrow, causing high blood pressure in the lungs and overworking the heart. PAH symptoms include difficulty breathing and reduced ability to be active. Current standard treatments address symptoms but do not stop disease progression. This Phase 3 study focuses on the long-term safety and tolerability of sotatercept when added to standard PAH therapy. Participants in this long-term follow-up study receive sotatercept through subcutaneous injections every three weeks. Only individuals who completed prior sotatercept PAH studies without early discontinuation may join. This study continues the observation and assessment of participants over an extended period to learn about the effects and safety of sotatercept combined with background PAH treatments. During the study, participants will be regularly monitored for adverse events, treatment discontinuations, and the presence of anti-drug antibodies for up to approximately 90 months. Laboratory tests will evaluate blood components such as platelets, hemoglobin, creatinine, bilirubin, and liver enzymes. Changes from baseline in body weight, blood pressure, and electrocardiogram readings will also be tracked. The study involves adherence to visit schedules and compliance with study procedures to ensure comprehensive long-term safety data collection.

Researchers are investigating BGB-16673, a targeted protein degrader aimed at treating various B-cell cancers including marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström macroglobulinemia, and diffuse large B-cell lymphoma. The study includes both Phase 1 and Phase 2 parts to determine safe and effective dosing and to evaluate the drug's response in patients. The trial is conducted under the new company name BeOne Medicines, previously known as BeiGene. The treatment involves oral administration of BGB-16673. Phase 1 focuses on dose escalation and safety expansion to identify the maximum tolerated dose and recommended dose for expansion over approximately 28 days to 3 years. Phase 2 includes expansion cohorts to assess overall response rates over about 3 years. Participants may have prior treatments including Bruton tyrosine kinase inhibitors and other anticancer therapies depending on their cancer type and study phase. Participants will be monitored closely with assessments of adverse events from the first dose until 30 days after the last dose or before starting new therapy, whichever comes first, for up to 47 weeks. The study measures tolerability, dosing recommendations, and treatment response. Eligibility assessments include performance status and measurable disease, with safety and response evaluations continuing through both phases for up to three years.

Researchers are evaluating BMS-986506 in people with advanced Clear Cell Renal Cell Carcinoma (ccRCC), a type of kidney cancer. This Phase 1/1b open-label study aims to determine if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC, especially those who have already received prior treatments including immunotherapy and targeted therapies. Participants receive specified doses of BMS-986506 on certain days as part of the treatment. The study includes two parts: part 1 involving participants who have had at least two prior treatment plans including immunotherapy and targeted therapy, and part 2 involving participants who have had at least one standard treatment including both a PD-1/L1 inhibitor and a VEGF-TKI. The treatment is given orally without altering the medication form. During the study, researchers monitor participants for adverse events, serious adverse events, dose-limiting toxicities, events leading to discontinuation, and deaths, using criteria up to about 2 years after the first dose. Participants are assessed for performance status and oxygen levels, and safety is carefully tracked to evaluate the effects of BMS-986506 over time.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

This research aims to evaluate the effects of Palynziq (pegvaliase) treatment on pregnant women with maternal phenylketonuria (PKU) and their babies. It focuses on women who were exposed to pegvaliase at any time during pregnancy and breastfeeding. The study's goal is to understand maternal, fetal, and infant outcomes related to this exposure. The study includes women who were treated with pegvaliase within two weeks before their last menstrual period and continued through pregnancy and breastfeeding. Data will be collected retrospectively for at least three months before pregnancy, throughout the pregnancy, and during the infant's first year of life. The exposure to pegvaliase during each trimester and breastfeeding period will be recorded. Individual participation will last up to approximately 21 months. Participants will provide consent and allow researchers to gather medical information from their healthcare providers and their infant's providers. Data collected includes pregnancy outcomes and infant development over a 10-year period following pegvaliase exposure. The study will monitor maternal and infant health through medical records and follow-ups during pregnancy and the first year of life, ensuring thorough observation of treatment effects over time.