Colima

Researchers are investigating the effects of vericiguat compared to a placebo in children with heart failure caused by left ventricular systolic dysfunction. This study aims to see if vericiguat is better than a placebo at lowering levels of a heart failure marker called NT-proBNP over 16 weeks. The trial includes a base period and an optional extension period to further evaluate safety and long-term effects. During the base period, participants receive vericiguat orally once daily either as tablets in doses of 2.5 mg, 5 mg, or 10 mg, or as a suspension of 0.2 mgmL or 1 mgmL for up to 52 weeks. Another group receives a placebo in matching forms and schedules. After completing the base period, eligible participants may join the extension period, where they continue to receive vericiguat under similar dosing for additional monitoring. Participants will undergo regular assessments, including measuring NT-proBNP levels at baseline, Week 16, and Week 52 during the base period, as well as monitoring heart events and adverse effects. In the extension period, safety is tracked for up to 8 years, including adverse events and reasons for stopping the study drug. Pharmacokinetics of vericiguat are also studied through blood sampling at scheduled weeks. The total participation time may extend over several years for those in the extension phase.

Researchers are studying the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders FAPD in children aged 4 to 18 years. The trial aims to determine if trimebutine, probiotics, or their combination can reduce symptoms of FAPD, including Irritable Bowel Syndrome, Functional Dyspepsia, Abdominal Migraine, and Functional Abdominal Pain Not Otherwise Specified. Participants are selected based on Rome IV criteria and are divided into three treatment groups to compare their effects. Participants will be randomly assigned to one of three groups trimebutine combined with probiotics, probiotics with placebo, or trimebutine with placebo. Trimebutine is given at 15 mgkgday divided into two doses, while probiotics consist of Lactobacillus rhamnosus 5 billion CFUs in a single nightly chewable tablet. The placebo is a microcrystalline cellulose tablet taken once nightly. Treatments last for 8 weeks, with patient follow-up at 4 and 8 weeks to evaluate symptom changes. During the study, participants will complete questionnaires based on Rome IV criteria to assess symptoms, and pain intensity will be measured using the Visual Analog Scale VAS. Quality of life will be evaluated with the PedsQL 4.0 scale. Follow-up visits at 4 and 8 weeks will reassess symptoms and treatment response. Researchers will monitor treatment adherence and remove participants who withdraw, have low adherence, or participate in other studies. The primary outcome is the average pain score change from baseline to 8 weeks.

Researchers are studying adults with stage 5 chronic kidney disease who are undergoing maintenance hemodialysis. The trial aims to evaluate how creatine monohydrate supplementation and a supervised exercise program during dialysis affect body composition, biochemical markers, and physical function. This double-blind, randomized clinical trial compares the separate and combined impacts of these interventions over an 8-week period. Participants will be assigned to one of four groups standard hemodialysis care, creatine supplementation, intradialytic exercise, or a combination of creatine and exercise. Creatine or placebo is given daily, with dosing times adjusted on dialysis and non-dialysis days. The exercise program includes aerobic and resistance activities performed three times weekly during dialysis sessions. The intervention lasts for 8 weeks. Throughout the study, participants will have assessments of muscle strength, body composition, and biochemical parameters at baseline and after the intervention. Researchers will measure grasping muscle strength as the primary outcome. The trial includes safety monitoring for adverse events related to creatine use. Participation spans the 8-week intervention period with regular exercise and supplement administration alongside routine dialysis care.