Saraland

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation CIC. This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the safety and effectiveness of atogepant, a medication approved for adults with migraine, in children and teens aged 6 to 17 who have a history of episodic migraine. This Phase 3 study addresses the limited approved treatments available for pediatric migraine sufferers and aims to better understand atogepants impact on this younger population. Participants will be randomly assigned to one of six groups based on age and dosage. Children aged 6 to 11 will participate in a pharmacokinetic substudy to determine the appropriate dose before receiving either placebo, low-dose, or high-dose atogepant tablets once daily for 12 weeks. Teens aged 12 to 17 will be randomized to receive placebo, low-dose, or high-dose atogepant tablets daily for 12 weeks. After this period, participants may have a follow-up visit 4 weeks after their last dose or join an extension study to continue atogepant treatment for an additional 52 weeks. During the study, participants will attend regular hospital or clinic visits for medical evaluations, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in the number of migraine and headache days, medication use, quality of life, and migraine-related disability. Safety will be monitored through adverse event reporting up to 16 weeks. The total study duration includes the 12-week treatment period with possible extension and follow-up assessments.

Researchers are conducting a multicenter, randomized, double-blind Phase 2 study to evaluate the pharmacodynamics, safety, and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484 alone, inclisiran alone, and placebo in adults with hypertension and hypercholesterolemia. The study focuses on understanding how these treatments affect certain blood markers and blood pressure in this population. Participants receive a single dose of either the combination of QCZ484 and inclisiran, QCZ484 alone, inclisiran alone, or placebo on Day 1. The study lasts up to 12 months and includes a screening period with two visits to confirm eligibility, followed by the treatment administration at the baselinerandomization visit. After treatment, participants enter a safety follow-up phase, with an option to join an open-label extension study instead of the follow-up. During the study, participants undergo various assessments including measurements of PCSK9 and AGT levels at baseline and Month 3, blood pressure and LDL cholesterol levels at baseline, Month 3, and Month 6, along with monitoring for treatment-emergent adverse events and changes in laboratory tests and vital signs for up to 12 months. These evaluations help researchers understand the effects and safety of the treatments over time.

Researchers are studying the effects of camlipixant in adults with two types of irritable bowel syndrome IBS-D diarrhea-predominant and IBS-M mixed type. This Phase 2b trial aims to assess how well camlipixant works and how safe it is when compared to a placebo. The study includes two parts, where after the first part, some participants may be randomly assigned to receive a higher dose of camlipixant or stop taking the drug. Participants receive camlipixant at different dose levels or a placebo during the first part of the study. In the second part, all participants are randomized again to either continue with camlipixant or placebo. The treatment lasts up to 26 weeks, with doses adjusted in the second phase. The study uses a triple-blind design where neither participants nor researchers know who receives which treatment during the trial. During the study, participants will regularly report their abdominal pain intensity and stool form using specific scoring systems. Researchers will monitor safety by tracking adverse events and changes in vital signs and laboratory tests. The main outcome measures focus on changes in abdominal pain intensity over weeks 7 to 12. Participants will be assessed throughout the 26-week period to evaluate the treatments effects and safety.

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase IIIII trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.

Researchers are evaluating combinations of targeted drugs in people with advanced non-small cell lung cancer that has spread and shows specific changes in the EGFR and MET genes. This phase II Lung-MAP trial focuses on patients whose cancer has progressed after treatment with osimertinib and aims to compare the effectiveness of combining capmatinib, osimertinib, and ramucirumab. The study also investigates safety, response rates, and survival outcomes while collecting biological samples for further analysis. Participants are randomly assigned to one of two groups. One group receives capmatinib and osimertinib as oral medications plus ramucirumab given intravenously, while the other group receives only capmatinib and osimertinib orally. During the trial, patients undergo regular CT or MRI scans and blood sample collections to monitor their disease and treatment effects. The study includes detailed assessments of tumor responses and side effects over time. Throughout the trial, participants will have scans and blood tests at scheduled intervals to assess disease progression and treatment impact. Researchers will monitor progression-free survival as the main outcome, along with response duration and toxicity. Blood samples are also collected to study circulating tumor DNA. The study continues up to three years, with ongoing safety and efficacy evaluations. Participants must meet specific health criteria and provide informed consent before joining.

Researchers are evaluating the efficacy and safety of SPN-812 viloxazine extended release in children aged 4 to 5 years with Attention-DeficitHyperactivity Disorder ADHD. This phase 4 study is randomized, double-blind, placebo-controlled, and involves multiple centers. It aims to assess treatment effects and tolerability in this preschool-age group with ADHD symptoms confirmed by specific diagnostic criteria. Participants will be randomly assigned to receive either 100mg of SPN-812 or a placebo once daily for 6 weeks. The study includes a screening period of up to 4 weeks to determine eligibility. The total study duration for each participant is up to 10 weeks, during which the two groups will be compared to evaluate the impact of the medication versus placebo. During the study, children will be assessed using the Attention-DeficitHyperactivity Disorder Rating Scale, 4th Edition, Preschool Version ADHD-RS-IV-P and the Clinical Global Impression scales to measure symptom severity and change. Safety and tolerability will be monitored throughout. Parents or guardians will provide consent, and children will participate in structured activities to help evaluate their symptoms outside the home. Regular study visits will include clinical evaluations and monitoring over the 6-week treatment period.

Researchers are evaluating the use of lanreotide before surgery compared to surgery alone to prevent pancreatic fistulas in patients with pancreatic cancer or pancreatic lesions that might become cancerous. This phase III trial aims to see if lanreotide, a drug similar to the bodys hormone somatostatin and used in certain tumors, can reduce complications like pancreatic fistulas after distal pancreatectomy surgery. Participants are randomly assigned to receive either lanreotide or a saline placebo by a quick injection under the skin within 36 hours before their planned distal pancreatectomy. Blood samples will be taken before surgery and on the first and third days after surgery, with possible collection of pancreatic fluid on these days as well. After surgery, patients will be followed up at 4, 8, and 12 months. During the study, researchers will assess the occurrence of pancreatic fistulas within 60 days after surgery, hospital stay length, and quality of life changes using specific questionnaires. They will also monitor other postoperative complications and the time to start any additional chemotherapy. Blood, pancreatic fluid, and tissue samples will be collected for future research, with all participants monitored carefully throughout the study period.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.