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Found 6 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating how well brenipatide LY3537031 is tolerated, its side effects, and its safety and effectiveness in adults with Irritable Bowel Syndrome-Constipation IBS-C. This Phase 2 study compares brenipatide given under the skin with a placebo to better understand its impact on IBS-C symptoms. The trial is sponsored by Eli Lilly and Company and lasts about 35 weeks. Participants will receive either brenipatide or a placebo, both administered subcutaneously. The study uses a randomized, double-blind, placebo-controlled design with parallel groups. Treatment effects will be measured primarily between weeks 9 and 16, focusing on the weekly composite clinical response. Secondary outcomes include abdominal pain and bowel movement responses during the same period. During the study, participants will be monitored for safety and symptom changes. They will record abdominal pain scores daily and bowel habits using a stool form scale. Researchers will review these data along with other health assessments to evaluate the study drugs effects. The total participation duration is approximately 35 weeks, including screening, treatment, and follow-up periods.

Age: 18Years - 75YearsAll GendersPhase 2
70 locations
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Actively Recruiting

Researchers are evaluating the safety, side effects, and effectiveness of brenipatide LY3537031 in adults with Irritable Bowel Syndrome-Diarrhea IBS-D. The study compares brenipatide administered under the skin with a placebo to understand its impact on this condition. This Phase 2 clinical trial involves participants aged 18 to 75 years. Participants will receive either the study drug brenipatide or a placebo through subcutaneous injections. The study follows a randomized, double-blind design where neither participants nor researchers know which treatment is given. Treatment and placebo administrations occur during the trial, which lasts approximately 35 weeks. During the study, participants will be monitored for how well they tolerate the drug and any side effects. Researchers will collect daily data on abdominal pain and stool consistency using an eDiary, focusing on responses between weeks 9 and 24. The primary measure is the percentage of participants achieving a daily composite response for at least half the days between weeks 9 and 16. Safety and efficacy outcomes are tracked throughout the trial period.

Age: 18Years - 75YearsAll GendersPhase 2
89 locations
P

Actively Recruiting

Healthy Volunteer

Researchers are evaluating the safety and immune response of a new 24-valent pneumococcal conjugate vaccine called PCV24 in children aged 2 months to 5 years. This phase 2 clinical trial is randomized, double-blind, and compares PCV24 to an existing vaccine, Prevenar13, to better understand its effects in young children. The study is sponsored by Sinovac Life Sciences Co., Ltd and aims to gather important data on this vaccines performance in the pediatric population. Participants will be randomly assigned to receive either the Sinovac PCV24 vaccine or the Prevenar vaccine. Both vaccines are given as 0.5 mL injections into the muscle, following age-appropriate immunization schedules. The trial includes different age groups within the 2 months to 5 years range, ensuring the vaccine is assessed across a broad pediatric population. During the study, children will be monitored for immune response by measuring pneumococcal serotype-specific antibodies 30 days after vaccination. Safety is also closely observed, tracking any adverse reactions within 30 days and serious events up to six months after the last dose. Guardians will be required to follow study procedures and maintain contact throughout the trial, which will continue until December 2027.

Age: 42Days - 5YearsAll GendersPhase 2
3 locations
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Actively Recruiting

Researchers are evaluating the effects of different doses of colchicine on cardiovascular health in Chinese patients with coronary heart disease CHD who have undergone percutaneous coronary intervention PCI. This phase 3, multicenter, prospective, randomized, controlled, double-blind study aims to determine whether long-term colchicine treatment reduces cardiovascular events and to assess the safety of these doses in this population. The study addresses the uncertainty about the standard colchicine doses suitability for Chinese patients due to differences in body weight and lack of large-scale evidence in China. Participants will be randomly assigned to one of three groups colchicine 0.5 mg daily, colchicine 0.375 mg daily, or placebo, each taken as one oral pill per day. The study includes follow-up visits at months 1, 6, 12, 18, 24, and continuing every six months thereafter, with phone assessments alternating every three months. All participants will also receive standard treatments for CHD such as antiplatelets and management of related conditions according to national guidelines. Cardiovascular events and safety data will be regularly monitored by independent committees, with an interim analysis planned once about half of the primary endpoints have occurred. Participants will be involved in scheduled visits and phone calls to monitor health status and collect information on cardiovascular events and adverse effects for an estimated 2 to 4 years. The main outcome measured is a combination of cardiovascular death, nonfatal heart attack, stroke, and ischemia-driven revascularization. Secondary outcomes include various cardiovascular events and overall mortality. Safety will be overseen by a Data and Safety Monitoring Board, and all suspected cardiovascular events will be reviewed by a blinded Clinical Event Committee to ensure accurate assessment throughout the study period.

Age: 18Years - 80YearsAll GendersPhase 3
36 locations
P

Actively Recruiting

Researchers are evaluating a new treatment regimen called MAAZA, which combines mitoxantrone hydrochloride liposomes with cytarabine and azacitidine, for adults newly diagnosed with primary Acute Myeloid Leukemia AML. This study compares the MAAZA regimen with the traditional DAAZA chemotherapy regimen to assess their effectiveness and safety in improving treatment outcomes for AML patients. The trial is a prospective, multicenter, randomized controlled study aiming to provide high-quality clinical evidence to improve AML treatment and prognosis. Participants are randomly assigned to one of two treatment groups. The MAAZA group receives mitoxantrone hydrochloride liposome 24 mgm2 intravenously on day 1 every 4 weeks, cytarabine 100 mgm2 intravenously every 12 hours for 7 days, and azacitidine 100 mg subcutaneously once daily for 7 days. The comparison group receives daunorubicin 60 mgm2 intravenously once daily for 3 days, cytarabine 100 mgm2 intravenously every 12 hours for 7 days, and azacitidine 100 mg subcutaneously once daily for 7 days. Each treatment cycle lasts 28 days. During the study, participants undergo evaluations including complete remission rates 2 to 3 weeks after the first treatment cycle. Researchers also monitor adverse events, remission rates, survival times, and mortality up to 100 months after randomization. Regular assessments include blood tests and physical health evaluations. The study lasts for multiple cycles and includes long-term follow-up to assess the overall impact of the treatments on patient survival and disease progression.

Age: 18Years - 75YearsAll GendersPhase 3
11 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating an artificial intelligence-based multimodal cognitive screening system to identify mild cognitive impairment MCI related to diabetes early in patients with type 2 diabetes mellitus T2DM. This observational study follows participants for 3 to 5 years to assess the systems accuracy and feasibility. The study also explores how diabetic metabolic indicators, such as glycemic variability and HbA1c levels, relate to changes in cognitive function, aiming to improve early detection and intervention for cognitive decline in T2DM patients. Participants are observed without additional interventions over the 3 to 5 years of follow-up. The study includes groups of participants with normal cognition and those with mild cognitive impairment. Cognitive status data are collected at the beginning and end of the study period, with no study drug or treatment administered. During the study, participants undergo cognitive assessments and monitoring of diabetic metabolic factors. Researchers measure the accuracy of the AI screening system in early detection and track the rate of cognitive decline over the follow-up period. The study also evaluates the predictive value of combining multiple types of data. Participants remain under observation with regular assessments, helping to understand the relationship between diabetes and cognitive changes over time.

Age: 40Years - 75YearsAll Genders
21 locations