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Found 598 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Researchers are evaluating how forming a physical activity PA identity within families can promote long-term physical activity among children aged 6 to 12 years. The study compares an identity formation approach, which includes education and planning plus additional coaching, to a standard education and planning condition. The main goal is to see if children in the identity formation group increase their moderate- to vigorous-intensity physical activity MVPA more over six months. Participants are divided into two groups. One group receives sessions, informational booklets, and worksheets based on Canadas PA guidelines, focusing on how parents can support their childs physical activity through encouragement, logistical help, and doing activities together. This group also receives materials on healthy family eating. The other group receives the same materials plus two extra coaching sessions that include family PA identity activities, such as assigning fun PA roles to family members and creating family PA items like t-shirts and photos, to strengthen social identity related to physical activity. During the six-month study, researchers will monitor childrens MVPA at baseline, 6 weeks, 3 months, and 6 months. Additional assessments include parent-child activity tracking through accelerometers and self-reports, body measurements, cardiovascular and musculoskeletal fitness tests, and social identity questionnaires. The study aims to understand how family support and identity impact childrens physical activity and health outcomes, with the University of Victoria leading the research.

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

Preterm birth, defined as birth before 37 weeks of gestation, occurs in about 8 percent of pregnancies in Canada and is linked to many health challenges, especially when it happens before 29 weeks. At this early stage, infants often face breathing difficulties and may require resuscitation. This trial compares resuscitation using either low 30% or high 60% oxygen levels to determine which approach results in better survival and neurodevelopmental outcomes at around 24 months of age. The study uses a cluster randomized crossover design where hospitals alternate between starting resuscitation with 30% or 60% oxygen for groups of 30 infants. Resuscitation includes standard care steps like lung expansion and ventilation support as needed. Oxygen is initially given at the assigned concentration for the first 5 minutes, then adjusted based on the infants oxygen saturation levels and heart rate over the next 5 minutes to maintain target saturation ranges. This approach aims to balance risks of too much or too little oxygen. Participants are infants born between 23 and 28 weeks gestation who receive full resuscitation at participating centers. During the study, infants have oxygen saturation monitored continuously, and adjustments to oxygen concentration are made carefully. Researchers will evaluate survival and major neurodevelopmental outcomes at 24 months corrected age, along with several safety and health measures during the neonatal intensive care stay. The trial is expected to provide important evidence to guide oxygen use during resuscitation of extremely preterm infants.

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

Researchers are evaluating different radiation treatments for men newly diagnosed with low volume oligometastatic prostate cancer, defined as fewer than five bone metastases andor non-regional lymph node involvement. The study aims to compare ultrahypofractionation using stereotactic ablative radiotherapy SABR or brachytherapy with moderately hypofractionated external beam radiotherapy EBRT to see if they are similarly well-tolerated. Secondary goals include assessing progression-free survival, overall survival, and cost-effectiveness. The trial hypothesizes that ultrahypofractionation will provide favorable toxicity profiles and quality of life while maintaining similar or better effectiveness, offering a convenient and cost-effective alternative to standard EBRT. Participants will be randomly assigned to one of four treatment groups standard EBRT delivering 5500 centiGray in 20 fractions over 4 weeks a single outpatient fraction of 19 Gray high dose rate brachytherapy under anesthesia a single outpatient permanent implant of radioactive Iodine-125 seeds delivering 125 Gy under anesthesia or SABR delivering 36.25 Gy in 5 fractions either weekly or every second day. Each treatment center selects its preferred brachytherapy or SABR option to balance enrollment across the four groups. During the study, urinary symptoms will be closely monitored over two years using the International Prostate Symptom Score IPSS at six time points. Additional assessments include quality of life questionnaires focusing on urinary, bowel, and sexual health, as well as biochemical markers, progression monitoring, survival, and cost-effectiveness over up to three years. Participants will complete these evaluations while receiving long-term androgen deprivation therapy and follow-up care to track treatment impact and safety.

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

This research investigates treatments for metastatic castration-resistant prostate cancer mCRPC focusing on a drug called ifinatamab deruxtecan I-DXd. The study aims to assess the safety, how well participants tolerate the treatments, and appropriate dosing levels of I-DXd alone or combined with other therapies. Researchers will also monitor participants prostate specific antigen PSA levels during treatment to understand its effects. Participants are assigned to one of several treatment groups. One group receives docetaxel every three weeks for up to 10 cycles. Other groups receive I-DXd alone or combined with either opevesostat or androgen receptor pathway inhibitors such as abiraterone acetate or enzalutamide. I-DXd is given every three weeks until unacceptable side effects, disease progression, death, or withdrawal, while the other drugs continue until specific discontinuation criteria are met. Premedication is required before each I-DXd dose to prevent nausea and vomiting. Throughout the study, participants undergo various assessments including monitoring of dose-limiting toxicities, adverse events, and PSA response rates. Researchers also track objective response rates, progression-free survival, overall survival, and other clinical outcomes over up to approximately 54 months. The study involves regular evaluations to assess safety and treatment effects until study completion.

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

Researchers are evaluating new treatment options for people living with HIV-1 Human Immunodeficiency Virus Type 1 who have not been treated before. The current standard treatment, antiretroviral therapy ART, involves taking multiple medicines daily and may cause other health problems. This study aims to compare a new study ART combining two medicines, islatravir and ulonivirine, taken once a week, against the standard daily ART to see if it works as well and is safe and tolerable. Participants will receive one of several treatments for 96 weeks the study ART with islatravir and ulonivirine taken once weekly, the standard ART with bictegraviremtricitabinetenofovir alafenamide BICFTCTAF taken once daily, or combinations involving placebos matching these treatments. The study includes two phases Phase 2 which is open-label, and Phase 3 which is double-blind and randomized. During the study, participants will have regular assessments including measuring the amount of HIV-1 RNA in their blood and monitoring for adverse events and medication tolerance. Researchers will evaluate how well the treatments control the virus and affect immune cells over 24, 48, and 96 weeks. Safety monitoring will continue for about 102 weeks. The total study duration for participants is up to 96 weeks of treatment plus follow-up.

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

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

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

Researchers are evaluating the efficacy and safety of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight and type 2 diabetes mellitus T2DM. This Phase III study aims to better understand how enicepatide affects body weight and other health measures in this population. Participants will be randomly assigned to receive either placebo or one of three dosing regimens of enicepatide, administered once weekly using an integrated drug-device combination product. The study lasts for 72 weeks, during which participants will self-administer the study drug or receive injections from a trained individual if needed. Throughout the study, participants will undergo various assessments including body weight, hemoglobin A1c, waist circumference, fasting glucose and insulin, cholesterol levels, blood pressure, and quality of life questionnaires. Safety will be monitored through adverse event reporting and specific rating scales. This comprehensive evaluation will help determine the effects of enicepatide on weight and diabetes management over the study period.

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

Researchers are evaluating two standard doses of the anti-cancer drug bevacizumab combined with chemotherapy in patients with epithelial ovarian cancer that is resistant to platinum-based chemotherapy. This pragmatic, randomized trial aims to compare a lower dose 7.5 mgkg versus a higher dose 15 mgkg of bevacizumab to see if the lower dose is not worse than the higher dose in controlling cancer progression while potentially reducing side effects and treatment costs. Participants will be randomly assigned to receive either 7.5 mgkg or 15 mgkg doses of bevacizumab every three weeks, combined with chemotherapy. The treatment duration will be determined by the treating clinicians based on standard care. The study compares progression-free survival, side effects, quality of life, and drug cost savings between the two dosing groups. During the study, participants will undergo regular CT scans to monitor disease progression, and side effects will be tracked. Quality of life assessments will be conducted during treatment and four weeks after stopping treatment. Researchers will follow participants for up to four years to assess progression-free survival and overall survival, along with treatment response duration and adverse events. Safety and treatment outcomes will be carefully monitored throughout the trial.

Age: 18Years +FEMALEPhase 2
2 locations
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Actively Recruiting

Researchers are evaluating BGB-16673, an oral drug, in adults with various types of B-cell malignancies such as marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenstrm macroglobulinemia, diffuse large B-cell lymphoma, and Richters transformation. This study includes Phase 1 dose finding and safety expansion, followed by Phase 2 expansion cohorts to determine recommended doses and further assess safety and efficacy. The study is divided into several parts, starting with Phase 1 dose escalation to find safe dosage levels, including monotherapy dose escalation and safety expansion in selected doses. Phase 2 involves expansion cohorts where participants receive the recommended doses identified in Phase 1 for further safety and efficacy evaluation. Some cohorts include participants who have not received prior BTK inhibitors, and Japanese participants are also enrolled to assess safety. Treatments are orally administered. Participants will undergo regular assessments including monitoring for adverse events, disease response, and drug concentration levels in the blood at various time points. Researchers will measure outcomes such as overall response rate and progression-free survival over approximately three years. Safety and tolerability will be closely tracked, and quality of life questionnaires will be completed at scheduled intervals. Participation may last several years, including follow-up periods to monitor long-term effects.

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

Researchers are evaluating the dose-response relationship of galvokimig compared with placebo in adults with moderate-to-severe atopic dermatitis AtD. The study focuses on participants who have had chronic AtD for at least one year and aims to assess how different doses of galvokimig impact the condition. This phase 2 trial is designed to better understand the drugs effects on symptoms and safety in this population. Participants are randomly assigned to one of several groups receiving different predefined doses of galvokimig or a matching placebo during an initial 16-week intervention period. After week 16, participants continue treatment with the same or a modified dose of galvokimig. The study uses a double-blind design to compare the effects of these doses on atopic dermatitis. During the study, participants will undergo regular assessments including the Eczema Area and Severity Index EASI, Investigator Global Assessment vIGA, and Peak Pruritus Numerical Rating Scale PP-NRS. Safety is monitored through reported adverse events up to week 58. The primary outcome is the percentage of participants achieving a significant improvement in EASI score at week 16. The total study duration extends beyond 16 weeks to include ongoing safety and response evaluations.

Age: 18Years +All GendersPhase 2
68 locations

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