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Found 609 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating blood biomarkers to classify injury severity and predict neurological recovery in patients with acute traumatic spinal cord injuries (SCI). This single-center study focuses on patients with cervical and thoracic SCI and aims to validate serum Neurofilament Light Chain (NF-L) and Glial Fibrillary Acidic Protein (GFAP) as indicators of injury severity and recovery. It also assesses the relationship between serum and plasma levels of these markers, the accuracy of point-of-care devices for GFAP measurement, and supports biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB). Participants include those with blunt traumatic spinal cord injuries or spinal fractures without neurologic injury. Blood samples will be collected daily for the first week after injury, using arterial, central, or intravenous lines. The study enrolls both SCI participants and non-SCI spine trauma controls. Neurologic assessments will be conducted at 6 and 12 months post-injury to monitor recovery. During the study, researchers will measure specific biochemical markers in the blood from Day 1 to Day 7. Participants will be closely monitored with neurologic evaluations at follow-up visits to assess recovery progress. The study also involves the use of point-of-care devices to measure biomarkers and contributes to an international biobank. The total involvement includes acute monitoring and longer-term follow-up over a year.

Age: 19Years +All Genders
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are investigating how forming a family physical activity (PA) identity can promote long-term physical activity in children aged 6 to 12 years. They aim to find out if a family identity formation approach, which includes education and planning, increases children's moderate to vigorous physical activity (MVPA) more than a standard education and planning program after six months. The study also explores if this approach improves children's health-related fitness and how parental support and family dynamics may influence these outcomes. Participants in the social identity group receive standard education and planning plus two extra sessions focused on developing a family PA identity. These sessions include education on PA benefits as a family, creating a family PA action plan, assigning fun family PA roles, and activities like making a family PA t-shirt and displaying family PA photos. The second session focuses on parental support identity using behavior change principles. The study is behavioral and does not involve medication or devices. Families will be involved for six months, with assessments at baseline, 6 weeks, 3 months, and 6 months to measure changes in children's physical activity. Researchers will evaluate child MVPA levels, health-related fitness, and the role of parental support using questionnaires and activity tracking. The study also monitors safety through a Physical Activity Readiness Questionnaire and includes families from specific regions in British Columbia. The total participation includes education, planning, coaching sessions, and follow-up assessments.

Age: 6Years - 12YearsAll GendersPhase Not Applicable
2 locations
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Actively Recruiting

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.

Age: 0Minutes - 10MinutesAll GendersPhase Not Applicable
21 locations
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Actively Recruiting

This research aims to compare different radiation treatments for men newly diagnosed with low volume oligometastatic prostate cancer, which means having fewer than five bone metastases or non-regional lymph node involvement. The study investigates whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as the standard moderately hypofractionated external beam radiotherapy (EBRT). Secondary goals include evaluating progression-free survival, overall survival, and cost-effectiveness, with the hope that ultrahypofractionation will offer similar or better outcomes with less toxicity and better quality of life. Participants will be randomly assigned to one of four treatment groups: standard EBRT delivering 5500 cGy in 20 fractions over 4 weeks; stereotactic body radiotherapy (SABR) delivering 36.25 Gy in 5 fractions over 2 to 5 weeks; permanent seed implant using Iodine-125 seeds implanted in the prostate; or a single high dose rate brachytherapy implant delivering 19 Gy via catheters. Each treatment is delivered at one of four cancer centers, with centers selecting their preferred alternative to the standard EBRT. During the two-year follow-up, participants will have urinary symptoms monitored at six time points using the International Prostate Symptom Score (IPSS). Other quality of life aspects, including urinary, bowel, and sexual function, will be assessed via questionnaires. Researchers will also track progression-free survival, overall survival, and cost-effectiveness. The total participation involves regular assessments over two years to evaluate the treatments' effects and tolerability.

Age: 18Years +MALEPhase Not Applicable
4 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) alone or combined with other treatments in people with metastatic castration-resistant prostate cancer (mCRPC). This study aims to understand how well patients tolerate the treatment, find a safe dose for combining I-DXd with other drugs, and measure prostate-specific antigen (PSA) levels during treatment. The study is part of a larger master screening protocol and includes patients with confirmed prostate adenocarcinoma who have progressive disease despite prior therapies. Participants receive treatments including I-DXd given through intravenous infusion, sometimes combined with other drugs such as docetaxel (IV), MK-5684, abiraterone, or enzalutamide (all oral). Before each I-DXd dose, patients take premedication to prevent nausea and vomiting. The study includes both a safety lead-in phase and an efficacy phase, with ongoing monitoring for side effects and tolerability. The combination therapies are carefully dosed and scheduled according to the study protocol. During the study, participants undergo regular assessments to monitor side effects, measure PSA response, and track any dose-limiting toxicities. Safety is closely followed, particularly during the first 21 days for combination treatments, and throughout up to 54 months for long-term outcomes. Researchers also observe if participants discontinue treatment due to adverse events. The study requires ongoing visits and evaluations to ensure participant health and collect data on treatment effects over time.

Age: 18Years +All GendersPhase 1Phase 2
78 locations
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Actively Recruiting

Researchers are studying a new treatment for HIV-1 infection that combines two medicines, islatravir and ulonivirine, taken once weekly. The goal is to see if this new study treatment works as well as the standard antiretroviral therapy (ART), which usually involves taking up to three medicines once or twice daily. This research also aims to learn about the safety and tolerability of the study treatment compared to the standard ART. The study compares the once-weekly combination of islatravir and ulonivirine with the standard daily treatment of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Participants will take either the study drugs or the standard drugs for 96 weeks. Some participants may receive matching placebos as part of the study design. The treatment is given orally as capsules or tablets according to the assigned group. Participants will be monitored throughout the study with regular assessments, including measuring the amount of HIV-1 virus in the blood to see if it is suppressed below 50 copies/mL at weeks 24 and 48. The study will also track any side effects or adverse events and whether participants stop the treatment due to these events. Overall, the study lasts about 96 weeks, with ongoing safety and effectiveness evaluations to understand how well the treatments work and how safe they are over time.

Age: 18Years +All GendersPhase 2Phase 3
53 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of enicepatide, a dual GLP-1/GIP receptor agonist, for managing weight in adults with obesity or overweight who also have Type 2 diabetes mellitus (T2DM). This Phase III study compares multiple doses of enicepatide to a placebo to understand its impact on weight loss in this population. Participants receive either enicepatide or a placebo once weekly through an integrated drug-device combination. The study uses a randomized, double-blind, placebo-controlled design to assess the effects of the treatment. The placebo is volume-matched and administered using the same method as the active drug. During the study, participants will have their body weight changes measured up to week 72 to assess efficacy. Researchers will monitor weight changes as the primary outcome. Participants must be able to self-administer the injections or receive them from a trained individual, and their safety and adherence will be observed throughout the study period.

Age: 18Years +All GendersPhase 3
36 locations
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Actively Recruiting

Researchers are evaluating two standard doses of the anti-cancer drug bevacizumab, combined with chemotherapy, in women with platinum-resistant ovarian cancer. This phase 2 pragmatic trial aims to compare a lower dose (7.5 mg/kg) versus a higher dose (15 mg/kg) of bevacizumab to see if the lower dose is not less effective, while potentially causing fewer side effects. Both doses are standard in treating ovarian cancer, but only the higher dose is typically used for platinum-resistant cases. The study hopes to determine if the lower dose could change clinical practice by offering similar cancer control with better safety and cost benefits. Participants are randomly assigned to receive either 7.5 mg/kg or 15 mg/kg of bevacizumab every three weeks alongside chemotherapy. The length of treatment is decided by the treating doctors following standard care practices. Researchers will monitor how long the cancer is controlled using CT scans, track side effects, and assess quality of life between the two groups to compare their outcomes. Women in the study will undergo regular assessments including imaging scans to measure disease progression and side effect monitoring. The primary outcome is progression-free survival, measured from the time of randomization until the cancer worsens or the participant dies, assessed for up to four years. The study also includes quality of life evaluations and safety monitoring during treatment and follow-up. Total participation time depends on individual treatment duration and follow-up assessments.

Age: 18Years +FEMALEPhase 2
2 locations
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Actively Recruiting

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.

Age: 18Years +All GendersPhase 1Phase 2
128 locations
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Actively Recruiting

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Age: 18Years +All GendersPhase 3
373 locations

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